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Celiac Disease & Gluten-Free Diet Forums

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Celiac Disease & Gluten-Free Diet Blogs

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  • An Unmistakeable Journey
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  • Research on South African Celiac Tours
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  • Keating's Not-so-Glutenfree life
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  • Coeliac, or just plain unlucky?
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  • Searchin for a Primary Care Dr. In Redlands That is Knowledgeable about Celiac disease
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  • Celiac-Positive
  • Jason's Mommy's Blog
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  • I love my plant Cactus <3
  • Chele's Blog
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  • Blues Boulevard
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  • Michael Fowler's Blog
  • Living in Japan with Ceoliac Disease
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  • MJ
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  • HONG KONG GLUTEN, WHEAT FREE PRODUCTS
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  • Gail Marie's Blog
  • Healthy Food Healthy You
  • SydneyT1D - Diabetic and Celiac YouTuber!
  • GFGF's Blog
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  • SMAS: www.celiac.com
  • gardener1's Blog
  • Naezer's Blog
  • JordanBattenSymons' Blog
  • JillianC
  • Sugar's Blog
  • Blanche22's Blog
  • Jason's Blog
  • Gluten-Free Sisters :)
  • Eab12's Celiac Blog
  • ohiodad's Blog
  • Newly Self Diagnosed?
  • misscorpiothing's Blog
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  • Petroguy
  • abqrock's Blog
  • WhoKnew?'s Blog
  • Soap Opera Central
  • nurcan's Blog
  • Cindy's Blog
  • Daughter_of_TheLight's Blog
  • nopastanopizza's Blog
  • w8in4dave's Blog
  • Mr J's Blog
  • Rachel Keating's Blog
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  • krisb's Blog
  • deetee's Blog
  • CAC's Blog
  • EmilyLinn7's Blog
  • Teri Kiefer's Blog
  • happyasabeewithceliac's Blog
  • quietmorning01's Blog
  • jaimekochan's Blog
  • Cheryl
  • Seosamh's Blog
  • donna mae's Blog
  • Colleen's blog
  • DawnJ's Blog
  • Gluten Challenge
  • twins2's Blog
  • just trying to feel better's Blog
  • Celiac Teen
  • MNBelle blog
  • Gabe351's Blog
  • moosemalibu's Blog
  • Coeliac Disease or Coeliac Sprue or Non Tropical Sprue
  • karalto's Blog
  • deacon11's Blog
  • Nyxie's Blog
  • Swpocket's Blog
  • threeringfilly's Blog
  • Madison Papers: Living Gluten-Free in a Gluten-Full World
  • babinsky's Blog
  • prettycat's Blog
  • Celiac Diagnosis at Age 24 months in 1939
  • Sandy R's Blog
  • mary m's Blog
  • Jkrupp's Blog
  • Oreo1964's Blog
  • keyboard
  • Louisa's Blog
  • Guts & Brains
  • Gluten Free Betty
  • Jesse'sGirl's Blog
  • NewMom's Blog
  • Connie C.'s Blog
  • garden girl's Blog
  • april anne's Blog
  • 4xmom's Blog
  • benalexander60's Blog
  • missmyrtle's Blog
  • Jersey Shore wheat no more's Blog
  • swezzan's Blog
  • aheartsj's Blog
  • MeltheBrit's Blog
  • glutenfreecosmeticcounter
  • Reasons Why Tummy tuck is considered best to remove unwanted belly fat?
  • alfgarrie's Blog
  • SmidginMama's Blog
  • lws' Blog
  • KMBC2014's Blog
  • Musings and Lessons Learned
  • txwildflower65's Blog
  • Uncertain
  • jess4736's Blog
  • deedo's Blog
  • persistent~Tami's Blog
  • Posterboy's Blog
  • jferguson
  • tiffjake's Blog
  • KCG91's Blog
  • Yolo's Herbs & Other Healing Strategies
  • scrockwell's Blog
  • Sandra45's Blog
  • Theresa Marie's Blog
  • Skylark's Blog
  • JessicaB's Blog
  • Anna'sMommy's Blog
  • Skylark's Oops
  • Jehovah witnesses
  • Celiac in Seattle's Blog
  • March On
  • honeybeez's Blog
  • The Liberated Kitchen, redux
  • onceandagain's Blog
  • JoyfulM's Blog
  • keepingmybabysafe's Blog
  • To beer, with love...
  • nana b's Blog
  • kookooto's Blog
  • SunnyJ's Blog
  • Mia'smommy's Blog
  • Amanda's Blog
  • jldurrani's Blog
  • Why choosing Medical bracelets for women online is the true possible?
  • Carriefaith's Blog
  • acook's Blog
  • REAGS' Blog
  • gfreegirl0125's Blog
  • Gluten Free Recipes - Blog
  • avlocken's Blog
  • Thiamine Thiamine Thiamine
  • wilbragirl's Blog
  • Gluten and Maize-Free (gluten-free-MF)
  • Elimination Diet Challenge
  • DJ 14150
  • mnsny's Blog
  • Linda03's Blog
  • GFinDC's Blog
  • Kim UPST NY's Blog
  • cmc's Blog
  • blog comppergastta1986
  • JesikaBeth's Blog
  • Melissa
  • G-Free's Blog
  • miloandotis' Blog
  • Confessions of a Celiac
  • Know the significance of clean engine oil
  • bobhayes1's Blog
  • Robinbird's Blog
  • skurtz's Blog
  • Olivia's Blog
  • Jazzdncr222's Blog
  • Lemonade's Blog
  • k8k's Blog
  • celiaccoach&triathlete's Blog
  • Gluten Free Goodies
  • cherbourgbakes.blogspot.com
  • snow dogs' Blog
  • Rikki Tikki's Blog
  • lthurman1979's Blog
  • Sprue that :)'s Blog
  • twinkletoes' Blog
  • Ranking the best gluten free pizzas
  • Gluten Free Product
  • Wildcat Golfer's Blog
  • Becci's Blog
  • sillyker0nian's Blog
  • txplowgirl's Blog
  • Gluten Free Bread Blog
  • babygoose78's Blog
  • G-freegal12's Blog
  • kelcat's Blog
  • Heavy duty 0verhead crane
  • beckyk's Blog
  • pchick's Blog
  • NOT-IN-2gluten's Blog
  • PeachPie's Blog
  • Johny
  • Breezy32600's Blog
  • Edgymama's Gluten Free Journey
  • Geoff
  • audra's Blog
  • mfrklr's Blog
  • 2 chicks
  • I Need Help With Bread
  • the strong one has returned!
  • sabrina_B_Celiac's Blog
  • Gluten Free Pioneer's Blog
  • Theanine.
  • The Search of Hay
  • Vanessa
  • racecar16's Blog
  • JCH13's Blog
  • b&kmom's Blog
  • Gluten Free Foodies
  • NanaRobin's Blog
  • mdrumr8030's Blog
  • Sharon LaCouture's Blog
  • Zinc, Magnesium, and Selenium
  • sao155's Blog
  • Tabasco's Blog
  • Amanda Smith
  • mmc's Blog
  • xphile1121's Blog
  • golden exch
  • kerrih's Blog
  • jleb's Blog
  • RUGR8FUL's Blog
  • Brynja's Grain Free Kitchen
  • schneides123's Blog
  • Greenville, SC Gluten-Free Blog
  • ramiaha's Blog
  • Kathy P's Blogs
  • rock on!'s Blog
  • Carri Ninja's Blog
  • jerseygirl221's Blog
  • Pkhaselton's Blog
  • Hyperceliac Blog
  • abbiekir's Blog
  • Lasister's Thoughts
  • bashalove's Blog
  • Steph1's Blog
  • Etboces
  • Rantings of Tiffany
  • GlutenWrangler's Blog
  • kalie's Blog
  • Mommy Of A Gluten Free Child
  • ready2go's Blog
  • Maureen
  • Floridian's Blog
  • Bobbie41972's Blog
  • Everyday Victories
  • Intolerance issue? Helpppp!
  • Feisty
  • In the Beginning...
  • Cheri46's Blog
  • Acne after going gluten free
  • sissSTL's Blog
  • Elizabeth19's Blog
  • LindseyR's Blog
  • sue wiesbrook's Blog
  • I'm Hungry's Blog
  • badcasper's Blog
  • M L Graham's Blog
  • Wolicki's Blog
  • katiesalmons' Blog
  • CBC and celiac
  • Kaycee's Blog
  • wheatisbad's Blog
  • beamishmom's Blog
  • Celiac Ninja's Blog
  • scarlett54's Blog
  • GloriaZ's Blog
  • Holly F's Blog
  • Jackie's Blog
  • lbradley's Blog
  • TheSandWitch's Blog
  • Ginger Sturm's Blog
  • The Struggle is Real
  • whataboutmary's Blog
  • JABBER's Blog
  • morningstar38's Blog
  • Musings of a Celiac
  • Celiacchef's Blog
  • healthygirl's Blog
  • allybaby's Blog
  • MGrinter's Blog
  • LookingforAnswers15's Blog
  • Lis
  • Alilbratty's Blog
  • 3sisters' Blog
  • MGrinter's Blog
  • Amanda
  • felise's Blog
  • rochesterlynn's Blog
  • mle_ii's Blog
  • GlamourGetaways' Blog
  • greendog's Blog
  • Tabz's Blog
  • Smiller's Blog
  • my vent
  • newby to celiac?'s Blog
  • siren's Blog
  • myraljo's Blog
  • Relieved and confused
  • carb bingeing
  • scottish's Blog
  • maggiemay832's Blog
  • Cristina Barbara
  • ~~~AnnaBelle~~~'s Blog
  • nikky's Blog
  • Suzy-Q's Blog
  • mfarrell's Blog
  • Kat-Kat's Blog
  • Kelcie's Blog
  • cyoshimit's Blog
  • pasqualeb's Blog
  • My girlfriend has celiacs and she refuses to see a doctor
  • Ki-Ki29's Blog
  • mailmanrol's Blog
  • Sal Gal
  • WildBillCODY's Blog
  • Ann Messenger
  • aprilz's Blog
  • the gluten-free guy
  • gluten-free-wifey's Blog
  • Lynda MEADOWS's Blog
  • mellajane's Blog
  • Jaded's Celiac adventures in a non-celiac world.
  • booboobelly18's Blog
  • Dope show
  • Classic Celiac Blog
  • Keishalei's Blog
  • Bada
  • Sherry's blurbs
  • addict697's Blog
  • MIchael530btr's Blog
  • Shawn C
  • antono's Blog
  • Undiagnosed
  • little_d's Blog
  • Gluten, dairy, pineapple
  • The Fat (Celiac) Lady Sings
  • Periomike
  • Sue Mc's Blog
  • BloatusMaximus' Blog
  • It's just one cookie!
  • Kimmy
  • jacobsmom44's Blog
  • mjhere's Blog
  • tlipasek's Blog
  • You're Prescribing Me WHAT!?!
  • Kimmy
  • nybbles's Blog
  • Karla T.'s Blog
  • Young and dealing with celiacs
  • Celiac.com Podcast Edition
  • LCcrisp's Blog
  • ghfphd's allergy blog
  • https://www.bendglutenfree.com/
  • Costume's and GF Life
  • mjhere69's Blog
  • dedeadge's Blog
  • CeliacChoplin
  • Ravenworks' Blog
  • ahubbard83's Blog
  • celiac<3'sme!'s Blog
  • William Parsons
  • Gluten Free Breeze (formerly Brendygirl) Blog
  • Ivanna44's Blog
  • Daily Life and Compromising
  • Vonnie Mostat
  • Aly'smom's Blog
  • ar8's Blog
  • farid's Blog
  • Sandra Lee's Blog
  • Demertitis hepaformis no Celac
  • Vonnie Mostat, R.N.
  • beetle's Blog
  • Sandra Lee's Blog
  • carlyng4's Blog
  • totalallergyman's Blog
  • Kim
  • Vhips
  • twinsmom's Blog
  • Newbyliz's Blog
  • collgwg's Blog
  • Living in the Gluten Free World
  • lisajs38's Blog
  • Mary07's Blog
  • Treg immune celsl, short chain fatty acids, gut bacteria etc.
  • questions
  • A Blog by Yvonne (Vonnie) Mostat, RN
  • ROBIN
  • covsooze's Blog
  • HeartMagic's Blog
  • electromobileplace's Blog
  • Adventures of a Gluten Free Mom
  • Fiona S
  • bluff wallace's Blog
  • sweetbroadway's Blog
  • happybingf's Blog
  • Carla
  • jaru24's Blog
  • AngelaMH's Blog
  • collgwg's Blog
  • blueangel68's Blog
  • SimplyGF Blog
  • Jim L Christie
  • Debbie65's Blog
  • Alcohol, jaundice, and celiac
  • kmh6leh's Blog
  • Gluten Free Mastery
  • james
  • danandbetty1's Blog
  • Feline's Blog
  • Linda Atkinson
  • Auntie Lur: The Blog of a Young Girl
  • KathyNapoleone's Blog
  • Gluten Free and Specialty Diet Recipes
  • Why are people ignoring Celiac Disease, and not understanding how serious it actually is?
  • miasuziegirl's Blog
  • KikiUSA's Blog
  • Amyy's Blog
  • Pete Dixon
  • abigail's Blog
  • CHA's Blog
  • Eczema or Celiac Mom?'s Blog
  • Thoughts
  • International Conference on Gastroenterology
  • Deedle's Blog
  • krackers' Blog
  • cliniclfortin's Blog
  • Mike Menkes' Blog
  • Juanita's Blog
  • BARB OTTUM
  • holman's Blog
  • It's EVERYWHERE!
  • life's Blog
  • writer ann's Blog
  • Ally7's Blog
  • Gluten Busters: Gluten-Free Product Alerts by Celiac.com
  • K Espinoza
  • klc's Blog
  • Pizza&beer's Blog
  • CDiseaseMom's Blog
  • sidinator's Blog
  • Dr Rodney Ford's Blog
  • How and where is it safe to buy cryptocurrency?
  • lucedith's Blog
  • Random Thoughts
  • Kate
  • twin#1's Blog
  • myadrienne's Blog
  • Nampa-Boise Idaho
  • Ursa Major's Blog
  • bakingbarb's Blog
  • Does Celiac Cause Sensitivites To Rx's?
  • delana6303's Blog
  • psychologygrl25's Blog
  • Alcohol and Celiac Disease
  • How do we get it???
  • cooliactic_BOOM's Blog
  • GREAT GF eating in Toronto
  • Gluten-free Food Recommendations!
  • YAY! READ THIS!!
  • BROW-FREE DIET BLOG
  • carib168's Blog
  • A Healing Kitchen
  • Shawn s
  • AZ Gal's Blog
  • mom1's Blog
  • The Beginning - The Diagnosis
  • PeweeValleyKY's Blog
  • solange's Blog
  • Cate K's Blog
  • Layered Vegetable Baked Pasta (gluten-free Vegetarian Lasagna)
  • Gluten Free Teen by Ava
  • mtdawber's Blog
  • sweeet_pea's Blog
  • DCE's Blog
  • Infertility and Celiac Disease
  • What to do in the Mekong Delta in 1 Day?
  • glutenfreenew's Blog
  • Living in the Garden of Eden
  • toddzgrrl02's Blog
  • redface's Blog
  • Gluten Free High Protein
  • Ari
  • Great Harvest Chattanooga's Blog
  • CeliBelli's Blog
  • Aboluk's Blog
  • redface's Blog
  • Being in Control of Your Gluten-Free Diet on a Cruise Ship
  • jayshunee's Blog
  • lilactorgirl's Blog
  • Yummy or Yucky Gluten-Free Foods
  • Electra's Blog
  • Cocerned husband's Blog
  • lilactorgirl's Blog
  • A Little History - My Celiac Disease Diagnosis
  • How to line my stomach
  • sewfunky's Blog
  • Oscar's Blog
  • Chey's Blog
  • The Fun of Gluten-free Breastfeeding
  • Dawnie's Blog
  • Sneaky gluten free goodness!
  • Chicago cubs shirts- A perfect way of showing love towards the baseball team!
  • Granny Garbonzo's Blog
  • GFzinks09's Blog
  • How do I get the Celiac.com podcast on my mp3 player?
  • quantumsugar's Blog
  • Littlebit's Blog
  • Kimberly's Blog
  • Dayz's Blog
  • Swimming Breadcrumbs and Other Issues
  • Helen Burdass
  • celiacsupportnancy's Blog
  • Life of an Aggie Celiac
  • kyleandjra.jacobson's Blog
  • Hey! I'm Not "Allergic" to Wheat!
  • FoOdFaNaTic's Blog
  • Wendy Cohan, RN's Gluten-Free and Dairy-Free Cooking Classes
  • Lora Derry
  • Dr. Joel Goldman's Blog
  • The Ultimate Irony
  • Lora Derry
  • ACK514's Blog
  • katinagj's Blog
  • What Goes On, Goes In (Gluten in Skin Care Products)
  • What’s new in hydraulic fittings?
  • cannona3's Blog
  • citykatmm's Blog
  • Adventures in Gluten-Free Toddling
  • tahenderson67's Blog
  • The Dinner Party Drama—Two Guidelines to Assure a Pleasant Gluten-Free Experience
  • What’s new in hydraulic fittings?
  • sparkybear's Blog
  • justbikeit77's Blog
  • To "App" or Not to "App": The Use of Gluten Free Product List Computer Applications
  • Onangwatgo
  • Raine's Blog
  • lalla's Blog
  • To die for Cookie Crumb Gluten-Free Pie Crust
  • DeeTee33's Blog
  • http://glutenfreegroove.com/blog/
  • David2055's Blog
  • Gluten-Free at the Fancy Food Show in San Francisco
  • Kup wysokiej jakości paszporty, prawa jazdy, dowody osobiste
  • Janie's Blog
  • Managing Hives & Gluten Allergies
  • Bogaert's Blog
  • Janie's Blog
  • RaeD's Blog
  • Dizzying Disclaimers!
  • Dream Catcher's Blog
  • PinkZebra's Blog
  • Hibachi Food and Hidden Gluten Hazards (How to Celebrate Gluten-Free)
  • jktenner's Blog
  • OhSoTired's Blog
  • PinkZebra's Blog
  • gluten-free Lover's Blog
  • Gluen Free Health Australia
  • Melissamb21's Blog
  • Andy C's Blog
  • halabackgirl9129's Blog
  • Liam Edwards' Blog
  • Celiac Disease in Africa?
  • Suz's Blog
  • Gluten-Free Fast Food
  • Eldene Goosen
  • mis_chiff's Blog
  • gatakat's Blog
  • macocha's Blog
  • Newly Diagnosed Celiacs Needed for Study in Chicago
  • Elaine Anne
  • Poor Baby's Blog
  • the loonie celiac's Blog
  • jenlex's Blog
  • Sex Drive/Testosterone can be Depleted by Certain Foods
  • Sharon
  • samantha79's Blog
  • 21 Months into the Gluten-free Diet
  • WashingtonLady's Blog-a-log
  • James S. Reid's Blog
  • Living with a Gluten-Free Husband
  • Diane King
  • runner girl's Blog
  • kp3972's Blog
  • ellie_lynn's Blog
  • trayne91's Blog
  • Gluten-free Lipstick!
  • Debado
  • Nonna2's Blog
  • Schar Chocolate Hazelnut Bar (Gluten-Free)
  • Diane
  • pnltbox27's Blog
  • Live2BWell's Blog
  • melissajohnson's Blog
  • nvsmom's Blog
  • Diagnosed with Celiac Disease and Still Sick
  • Coming out having gluten intolerance and celiac disease
  • snowcoveredheart's Blog
  • Gluten Free Nurse
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  1. Celiac.com 06/27/2024 - For people with celiac disease who are attempting to maintain a gluten-free diet, there are some potential new treatment options on the horizon. Managing celiac disease means adhering to a strict gluten-free diet. Many people with celiac disease, who are attempting to maintain a gluten-free diet, continue to have regular or intermittent symptoms. In fact, research shows that is estimated that up to 50% of celiac disease patients have persistent symptoms while on the gluten-free diet. The most common reason for persistent symptoms is continuing to ingest gluten, often by accident. A clinical trial is currently evaluating the effectiveness of TAK-062 in reducing symptoms and improving small intestinal damage caused by gluten exposure. Here's what you need to know. Study Aim The main aim of the trial is to see how well TAK-062 reduces celiac-related symptoms, and improves small intestinal damage from gluten exposure, in people with celiac disease. Participants will receive either TAK-062 or a placebo to measure its impact against the control group. New Study on TAK-062 for Celiac Disease A new clinical trial is testing TAK-062, a potential treatment for people with celiac disease who are trying to follow a gluten-free diet. Here are the main points about who can join and who can't. Who Can Join the Study? Understanding of GFD: You need to know a lot about gluten-free diets. This will be checked by a test and confirmed by the study investigator. Symptoms: You must have at least one moderate or severe celiac-related symptom on three or more days in a week during the screening period. Diet History: You should have been trying to follow a gluten-free diet for at least 12 months. Intestinal Damage: You must have small intestinal damage, shown by a specific measure from a biopsy. Genetic Markers: You need to have the HLA-DQ2 and/or HLA-DQ8 genetic markers. Overall Health: You should be in good health based on a medical check-up. Body Mass Index (BMI): Your BMI should be between 16 and 45 kg/m². Consistency: You must be able to keep the same diet and medication routines during the study. Who Can't Join the Study? Other GI Disorders: If you have other inflammatory gut diseases or uncontrolled autoimmune diseases, you can't join. Immunosuppressant Use: If you’ve used systemic immunosuppressants or corticosteroids recently, you’re not eligible. Digestive Supplements: Using over-the-counter digestive enzymes or supplements for gluten digestion disqualifies you, except for lactase. Symptom Diary: You need to complete at least 75% of the symptom diary during the run-in period. Microscopic Colitis: Active microscopic colitis or a recent history of it disqualifies you. Refractory celiac disease: If you have type 2 refractory celiac disease or ulcerative jejunitis, you can't join. NSAIDs: Chronic use of NSAIDs, except for low-dose aspirin, disqualifies you. Villous Abnormalities: Using medications that cause villous damage means you can't join. Recent GI Treatments: Recent use of certain GI treatments or supplements disqualifies you. Severe Infections: A severe enteric infection in the past six months disqualifies you. Endoscopy Issues: If you can’t have an endoscopy, you can’t join. Food Allergies: Allergies to ingredients in the study food bar disqualify you. Drug Reactions: History of reactions to aminoglycosides disqualifies you. Infections: HIV, hepatitis B or C infections disqualify you. COVID-19: Testing positive for COVID-19 with symptoms that affect the study disqualifies you. Wheat/Gluten Allergy: Known wheat or gluten allergies disqualify you. Ingredient Sensitivity: Sensitivity to TAK-062 or placebo ingredients disqualifies you. Active Cancer: Current or recent cancer treatment disqualifies you, except for certain early-stage cancers. This trial is another of many that offers hope for a new therapeutic approach for managing celiac disease, potentially improving the quality of life for many individuals struggling with this condition. Find more information at classic.clinicaltrials.gov
  2. Celiac.com 12/23/2023 - Celiac disease, an autoimmune condition triggered by gluten consumption, has seen remarkable progress in recent research endeavors. This article delves into the latest breakthroughs, ongoing clinical trials, and the prospective landscape of celiac disease treatments. From innovative therapies to promising drug developments, the aim is to unravel the potential impact of these advancements on the lives of individuals with celiac disease. Understanding Celiac Disease: A Brief Overview Celiac disease stands as a multifaceted autoimmune condition triggered by the consumption of gluten, a protein found in wheat, barley, and rye. With a prevalence reaching approximately 1% of the global population, this chronic disorder poses unique challenges to individuals whose immune systems react adversely to gluten ingestion. At its core, celiac disease is characterized by an abnormal immune response that targets the small intestine. Gluten consumption sets off an inflammatory reaction, leading to damage to the lining of the small intestine and impairing its ability to absorb nutrients. This often results in a range of symptoms, from gastrointestinal distress and malabsorption issues to fatigue, joint pain, and neurological complications. Diagnosis is a multifaceted process involving a combination of blood tests, genetic testing, and, often, confirmation through an intestinal biopsy. It's crucial to recognize that celiac disease can manifest in diverse ways, making diagnosis challenging and underscoring the importance of comprehensive medical evaluation. For those diagnosed with celiac disease, the primary and only effective treatment is strict adherence to a gluten-free diet. By eliminating gluten-containing foods, individuals can manage symptoms, allow the small intestine to heal, and prevent complications associated with ongoing inflammation. As we embark on the exploration of recent research advances, it is paramount to grasp the fundamental aspects of celiac disease. This understanding lays the groundwork for appreciating the significance of breakthroughs, clinical trials, and emerging treatments in the dynamic landscape of celiac disease research. Genetic Research and Personalized Medicine Genetic research has emerged as a cornerstone in unraveling the complexities of celiac disease. The strong genetic component of the condition is underscored by the association with specific human leukocyte antigen (HLA) genes, particularly the HLA-DQ2 and HLA-DQ8 variants. Individuals carrying these genetic markers are more predisposed to developing celiac disease when exposed to gluten. Advancements in genetic research not only enhance our understanding of celiac disease's hereditary nature but also pave the way for personalized medicine approaches. Genetic testing allows for the identification of at-risk individuals, enabling targeted screening and early intervention. This precision in diagnosis is pivotal, as it empowers healthcare providers to tailor their approach based on an individual's genetic predisposition, optimizing the efficacy of interventions and improving overall patient outcomes. Moreover, ongoing genetic research delves into the intricate interplay of various genetic factors that contribute to the diverse manifestations of celiac disease. Unraveling these genetic intricacies holds the promise of unveiling novel therapeutic targets and refining risk prediction models. The integration of genetic insights into the realm of personalized medicine marks a paradigm shift in celiac disease management, steering us towards more nuanced and individualized approaches to diagnosis, treatment, and long-term care. As genetic research continues to unfold, the potential for groundbreaking discoveries that shape the future of celiac disease care becomes increasingly apparent. Breakthrough Therapies on the Horizon The quest for innovative and effective therapies for celiac disease has ushered in a new era of research and development. Breakthroughs on the horizon promise transformative approaches that go beyond the conventional reliance on a gluten-free diet. These pioneering therapies aim to address the underlying immune response and inflammation characteristic of celiac disease, providing new avenues for individuals seeking relief and an improved quality of life. One notable breakthrough involves the exploration of enzyme therapies designed to break down gluten in the digestive system, rendering it less immunogenic. These enzymes, often referred to as glutenases, hold the potential to mitigate the impact of accidental gluten exposure and offer individuals with celiac disease a degree of dietary flexibility. Immunomodulatory therapies represent another frontier in celiac disease research. By targeting specific components of the immune system responsible for the aberrant response to gluten, these therapies aim to modulate immune activity and alleviate the inflammatory cascade triggered by gluten ingestion. These approaches hold promise in not only managing symptoms but also addressing the root cause of celiac disease. Additionally, advancements in the realm of nanotechnology and drug delivery systems contribute to the development of novel strategies for gluten detoxification. Nanoparticle-based approaches seek to encapsulate gluten, preventing its interaction with the immune system and reducing its harmful effects on the intestine. While these breakthrough therapies are in various stages of preclinical and clinical development, their potential to revolutionize celiac disease management is evident. As research progresses, the prospect of a more diversified therapeutic landscape offers hope to individuals with celiac disease, signaling a future where effective treatments extend beyond dietary restrictions. Clinical Trials: Navigating the Path to Approval Clinical trials stand at the forefront of translating scientific discoveries into tangible treatments for celiac disease. These rigorous investigations represent a critical phase in the development of new therapies, assessing their safety, efficacy, and overall impact on patient outcomes. Navigating the path to approval involves a systematic and regulated approach, encompassing various phases that rigorously evaluate the intervention's viability and potential benefits. The journey begins with Phase 1 trials, where the focus is primarily on the therapy's safety profile. Small groups of participants are enrolled, and the treatment's tolerability and potential side effects are closely monitored. Following successful Phase 1 outcomes, researchers progress to Phase 2 trials, expanding the participant pool to assess both safety and initial efficacy in a larger and more diverse cohort. Phase 3 trials constitute a pivotal stage, involving a more extensive participant population to provide robust data on the therapy's effectiveness, safety, and optimal dosage. These trials often employ a randomized and controlled design, comparing the investigational therapy against a placebo or standard treatment to ensure statistically significant results. Upon completion of successful Phase 3 trials, researchers compile comprehensive data for regulatory submissions seeking approval from health authorities. Regulatory agencies meticulously review the evidence to ascertain the therapy's safety and efficacy, with the potential for market approval if deemed beneficial and safe for patient use. Engaging in clinical trials requires collaboration between researchers, healthcare professionals, and individuals with celiac disease who voluntarily participate in these groundbreaking studies. Their contributions play a pivotal role in advancing the field, bringing us closer to a future where novel therapies offer renewed hope and improved outcomes for the celiac community. Innovative Drug Developments In the dynamic landscape of celiac disease research, innovative drug developments are catalysts for transformative change. The pursuit of novel pharmaceutical interventions goes beyond traditional dietary restrictions, offering a spectrum of therapeutic possibilities. These groundbreaking developments aim to address the intricate immunological and inflammatory processes at the core of celiac disease, providing hope for enhanced management and improved quality of life for those affected. Monoclonal antibodies represent a forefront in innovative drug development for celiac disease. These antibodies are designed to specifically target and neutralize key components of the immune response associated with gluten-induced inflammation. By modulating immune activity, monoclonal antibodies hold promise in mitigating the damaging effects of gluten ingestion and preventing the cascade of events leading to intestinal damage. Small molecule drugs tailored to interrupt specific pathways involved in the immune response to gluten also feature prominently in ongoing research. These compounds, often designed to be orally administered, aim to provide a systemic impact on celiac disease, offering an alternative to dietary restrictions. As these drugs progress through clinical trials, their potential to revolutionize the therapeutic landscape becomes increasingly apparent. The exploration of microbiome-based therapies adds an additional layer of innovation to celiac disease drug development. Leveraging the intricate relationship between gut microbes and the immune system, these therapies seek to restore balance and tolerance to gluten. Manipulating the microbiome holds promise in creating a more resilient and tolerant gut environment, potentially reducing the severity of celiac disease symptoms. While these innovative drug developments are in various stages of research and clinical testing, their emergence signifies a paradigm shift in how we approach celiac disease. By expanding the therapeutic toolkit, researchers aim to provide individuals with celiac disease options that align with their unique needs and contribute to a future where effective pharmaceutical interventions coexist with dietary management. The Role of Diet and Nutritional Therapies Diet remains a cornerstone in managing celiac disease, and ongoing research continues to refine nutritional strategies to optimize health outcomes for individuals with this autoimmune condition. Understanding the intricate relationship between diet and celiac disease is crucial for effective symptom management, promoting gut healing, and ensuring overall well-being. Gluten-Free Diet: A Necessity for Celiac Disease Management The foundation of celiac disease management lies in the strict adherence to a gluten-free diet. Eliminating gluten-containing grains such as wheat, barley, and rye is essential to prevent immune-mediated damage to the small intestine. A gluten-free diet requires vigilance in scrutinizing food labels, choosing naturally gluten-free foods, and adopting gluten-free cooking practices to avoid cross-contamination. Beyond Gluten: Exploring Nutritional Support While the removal of gluten is non-negotiable for those with celiac disease, attention to overall nutritional support is equally vital. Deficiencies in key nutrients such as iron, calcium, vitamin D, and B vitamins are common in individuals with celiac disease due to malabsorption issues. Nutritional therapies focus on addressing these deficiencies through dietary modifications, supplementation, and monitoring. Potential of Microbiome Modulation Recent research highlights the dynamic interplay between the gut microbiome and celiac disease. The composition of gut bacteria influences immune responses and may play a role in the development and progression of the disease. Exploring nutritional strategies to modulate the microbiome, such as probiotic supplementation and prebiotic-rich foods, holds promise in promoting gut health and optimizing the nutritional status of individuals with celiac disease. Personalized Nutrition: Tailoring Dietary Approaches Recognizing the diverse presentations of celiac disease, researchers delve into the realm of personalized nutrition. Tailoring dietary approaches to individual needs considers factors such as symptom severity, coexisting conditions, and nutritional requirements. Personalized nutrition aims to enhance dietary compliance, address specific nutritional deficiencies, and improve the overall quality of life for those managing celiac disease. As our understanding of the intricate relationship between diet and celiac disease evolves, nutritional therapies continue to play a pivotal role in comprehensive management strategies. Balancing the strict requirements of a gluten-free diet with personalized nutritional support contributes to the holistic care of individuals with celiac disease, fostering optimal health and well-being. Challenges and Considerations in Celiac Disease Research As the landscape of celiac disease research expands, researchers face various challenges and considerations that shape the trajectory of scientific inquiry and impact the translation of findings into tangible advancements for patients. Navigating these complexities is crucial for fostering progress, ensuring the validity of research outcomes, and addressing the multifaceted nature of celiac disease. Heterogeneity in Celiac Disease Presentations Celiac disease exhibits a diverse spectrum of clinical presentations, ranging from classic gastrointestinal symptoms to atypical or silent forms. This heterogeneity poses a challenge in both diagnosis and research, as individuals may present with varying degrees of symptom severity and associated conditions. Researchers grapple with the need to account for this diversity in study cohorts, considering the implications for generalizability and personalized treatment approaches. Diagnostic Limitations and Evolving Criteria Accurate diagnosis is fundamental to celiac disease research, yet diagnostic criteria and tools continue to evolve. Serological tests, histological analysis, and genetic markers contribute to diagnosis, but challenges persist in cases of seronegative celiac disease and potential overlap with other gastrointestinal conditions. Researchers must navigate the nuances of diagnostic criteria, considering advancements and potential limitations in standardizing assessments across studies. Long-Term Implications and Outcomes Understanding the long-term implications of celiac disease, including its impact on quality of life, comorbidities, and associated complications, requires longitudinal research. Tracking outcomes over extended periods presents logistical challenges, including participant retention, data accuracy, and the dynamic nature of patient experiences. Longitudinal studies are essential for unraveling the multifaceted nature of celiac disease progression and its consequences. Interplay of Genetics, Environment, and Microbiome Celiac disease's etiology involves a complex interplay of genetic predisposition, environmental factors, and the gut microbiome. Untangling these interconnected elements presents a formidable challenge, as researchers strive to elucidate the role of specific genes, environmental triggers, and microbiome dynamics in disease onset and progression. Collaborative and interdisciplinary approaches are essential for comprehensively addressing these multifactorial influences. Translation of Research Findings into Clinical Practice Bridging the gap between research findings and clinical practice is a critical consideration in celiac disease research. Successful translation requires effective communication between researchers, healthcare providers, and individuals with celiac disease. Implementing evidence-based recommendations, disseminating research outcomes to diverse stakeholders, and fostering awareness are integral aspects of ensuring that advancements in research positively impact patient care. Addressing these challenges and considerations requires ongoing collaboration, innovation, and a commitment to advancing our understanding of celiac disease. As research endeavors continue, the collective efforts of the scientific community play a pivotal role in overcoming obstacles, refining diagnostic and therapeutic approaches, and ultimately improving outcomes for individuals living with celiac disease. Patient Perspectives: Voices from the Celiac Community In the realm of celiac disease research, the voices and experiences of individuals living with the condition provide invaluable insights that complement scientific findings. Patient perspectives offer a nuanced understanding of the challenges, triumphs, and day-to-day realities faced by those navigating life with celiac disease. These firsthand accounts contribute to the broader dialogue surrounding the condition and enrich both research initiatives and the broader celiac community. Navigating Diagnosis and Treatment Journeys Patients with celiac disease often encounter a labyrinthine journey in obtaining an accurate diagnosis and navigating subsequent treatment paths. Sharing personal stories illuminates the diverse pathways individuals take in seeking answers to their health concerns, from initial symptoms to the diagnostic process and the subsequent initiation of a gluten-free lifestyle. These narratives underscore the need for improved awareness, timely diagnosis, and accessible support networks. Quality of Life and Daily Challenges Understanding the impact of celiac disease on individuals' quality of life requires an exploration of the daily challenges they face. Patient perspectives shed light on the intricacies of managing a gluten-free diet, coping with social and emotional aspects, and addressing the broader implications of the condition on mental and physical well-being. Capturing these nuanced experiences informs research priorities, emphasizing the holistic needs of individuals with celiac disease. Advocacy and Community Engagement The celiac community is characterized by a strong spirit of advocacy and mutual support. Patient perspectives highlight the role of individuals in advocating for improved awareness, research funding, and policy changes that benefit the broader community. Engaging with patient advocacy groups, sharing success stories, and mobilizing collective efforts amplify the impact of patient voices in shaping the trajectory of celiac disease research and fostering a sense of community. Challenges and Triumphs in Gluten-Free Living Living gluten-free entails a myriad of challenges, from navigating restaurant menus to deciphering food labels and managing potential cross-contamination risks. Patient narratives capture the triumphs and tribulations of gluten-free living, offering practical insights into coping strategies, favorite recipes, and innovative approaches to enhancing the gluten-free lifestyle. These stories resonate with others facing similar challenges and provide a platform for shared learning and support. Collaboration Between Patients and Researchers The synergy between patients and researchers is integral to advancing celiac disease research. Patient perspectives contribute to research prioritization, study design, and the development of patient-centered outcomes. Collaborative initiatives that involve individuals with celiac disease in research endeavors foster a sense of shared ownership and promote research that is reflective of the diverse needs and experiences within the community. In amplifying the voices of the celiac community, patient perspectives serve as a powerful catalyst for positive change. By integrating these narratives into the fabric of celiac disease research, we honor the lived experiences of individuals, foster a more empathetic and informed approach to patient care, and collectively work towards a future where the journey with celiac disease is understood, supported, and empowered. The Future Landscape of Celiac Disease Treatment As the field of celiac disease research advances, the prospect of innovative and targeted treatments heralds a transformative era for individuals living with the condition. The future landscape of celiac disease treatment holds promise, with ongoing research endeavors exploring novel therapeutic avenues and potential interventions. This section delves into the evolving landscape of celiac disease treatment, highlighting key areas of exploration and envisioning the potential trajectory of future interventions. Immunomodulatory Therapies Immunomodulatory therapies represent a forefront area of investigation in celiac disease treatment. Researchers are exploring strategies aimed at modulating the immune response to gluten, thereby mitigating the inflammatory cascade that characterizes the condition. From targeted immunotherapies to interventions that induce gluten tolerance, the goal is to develop treatments that allow individuals with celiac disease greater dietary flexibility while maintaining immune balance. Enzyme Therapies and Gluten Digestion Enzyme therapies designed to enhance gluten digestion are emerging as a potential avenue for celiac disease management. These therapies involve the use of enzymes that break down gluten into non-immunogenic fragments, reducing the likelihood of triggering an immune response. While challenges exist in achieving complete gluten degradation, ongoing research explores the feasibility and safety of enzyme-based approaches as adjuncts to a gluten-free diet. Microbiome Modulation The gut microbiome's intricate role in celiac disease pathogenesis has sparked interest in microbiome modulation as a potential therapeutic strategy. Research aims to understand how specific microbial compositions influence gluten metabolism and immune responses. Modulating the microbiome through probiotics, prebiotics, or fecal microbiota transplantation represents a novel frontier in addressing the dysbiosis associated with celiac disease and fostering a gut environment conducive to tolerance. Personalized and Precision Medicine Advancements in personalized and precision medicine offer a tailored approach to celiac disease treatment. Genetic profiling, biomarker identification, and individualized treatment plans based on specific patient characteristics are integral components of this evolving paradigm. Tailoring interventions to address the heterogeneity of celiac disease presentations enhances treatment efficacy and aligns with the broader trend toward precision medicine in autoimmune conditions. Therapeutic Vaccines Therapeutic vaccines designed to induce immune tolerance to gluten are under investigation as potential interventions for celiac disease. These vaccines aim to reprogram the immune system's response to gluten, allowing individuals to consume gluten-containing foods without triggering an adverse reaction. While challenges related to vaccine design and long-term efficacy persist, ongoing research holds promise for a future where therapeutic vaccines become a viable treatment option. Patient-Centered Approaches and Shared Decision-Making The future landscape of celiac disease treatment emphasizes patient-centered approaches that prioritize individual preferences, values, and goals. Shared decision-making between healthcare providers and individuals with celiac disease becomes paramount in tailoring treatment plans to align with patients' lifestyle, dietary choices, and overall well-being. Empowering individuals with information and involving them in treatment decisions fosters a collaborative and patient-centric care model. While these potential avenues offer glimpses into the future of celiac disease treatment, ongoing research, clinical trials, and collaborative efforts will determine the feasibility, safety, and efficacy of these interventions. As the scientific community continues to unravel the complexities of celiac disease, the prospect of transformative treatments brings hope for enhanced quality of life and improved management strategies for individuals living with this autoimmune condition. Conclusion In navigating the intricate terrain of celiac disease research, this exploration reveals a landscape marked by significant strides, promising breakthroughs, and a collective commitment to transforming the lives of individuals affected by gluten intolerance. From the realms of genetic insights guiding personalized medicine to the forefront of innovative therapies and ongoing clinical trials, the journey towards effective celiac disease treatment is unfolding. As we envisage the future, a convergence of multidisciplinary approaches, patient-centered care, and cutting-edge pharmaceutical developments emerges. The synergy of researchers, healthcare professionals, and the resilient celiac community propels us towards a horizon where the burdens of celiac disease are lightened, and individuals can embrace a life unrestricted by the constraints of gluten intolerance. Yet, this journey is not without its challenges. Regulatory intricacies, the need for increased research funding, and the imperative for sustained patient advocacy underscore the complexity of the path ahead. In the face of these challenges, however, the resilience and determination witnessed in the celiac community serve as a beacon of hope, propelling research forward and fostering an environment where breakthroughs become a reality. The evolving narrative of celiac disease research paints a picture of optimism, collaboration, and a shared vision for a future where effective treatments abound. As we reflect on the progress made and anticipate what lies ahead, let us remain steadfast in our pursuit of alleviating the impact of celiac disease and championing a future where individuals can thrive without the constraints of gluten intolerance. Together, we stride towards a horizon where the promises of research translate into tangible improvements in the lives of those navigating the challenges of celiac disease. Further reading: Celiac Disease Foundation - Celiac Disease Foundation Research National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - Celiac Disease Research at NIDDK Clinical Trials Beyond Celiac - Research and Innovation Gluten Intolerance Group - Research and Education American College of Gastroenterology (ACG) - Celiac Disease Overview PubMed - Celiac Disease Research Articles

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  4. Celiac.com 07/18/2022 - Currently, a gluten-free diet is the only treatment for people with celiac disease. A number of companies have been attempting to create treatments that reduce or eliminate celiac disease symptoms, mostly for patients on a gluten-free diet. Larazotide, whose clinical trial is dubbed "CedLara," is such a drug. It's designed to reduce persistent celiac disease symptoms for people on a gluten-free diet. In an earlier phase 2 trial, Larazotide was shown to reduce celiac symptoms in patients who had been on a gluten-free diet for at least 12 months. Many were excited to see how it would do in a phase 3 trial. The answer, unless we get some better news from 9 Meters Biopharma, the company that has been developing it, is badly. For the phase 3 trial, 9 Meters Biopharma set out to enroll 525 patients in the phase 3 trial to determine the effect of larazotide on celiac disease severity. To determine the number of people needed to measure a statistically significant effect, the company conducted an analysis with half of the expected patients enrolled. According to a company news release, their analysis showed that the additional number of patients needed to produce a significant clinical outcome between placebo and Larazotide is too large for the company to pursue. Reading between the lines of the news release, it seems as though the the company might need far more test subject than originally estimated to show a statistically significant result. That means that, no matter how effective the drug was for some people, the company can't afford to test in large enough numbers to show that it's genuinely effective. With the failure of Larazotide, 9 Meters Biopharma announced that it will be pivoting to the development of vurolenatide, a repeated injection aimed at increasing nutrient absorption in patients with short bowel syndrome. Phase 2 results should be unveiled soon. The failure of Larazotide marks the latest addition to the growing graveyard of celiac disease drugs. As Larazotide has been touted since 2013, this failure is particularly disappointing. To punctuate the ignoble end for a once hopeful drug, the company's CEO and president, John Temperato, says that financial and human resources from Larazotide will be reassigned to advance vurolenatide and the company’s early-stage product candidates, pending a review. Read more at seekingalpha.com
  5. Celiac.com 09/05/2022 - According to studies, most people with celiac disease are exposed to gluten on a regular basis, even those who are trying to be diligent about avoiding gluten. For these people, eating gluten can trigger gastrointestinal symptoms and intestinal damage. Anyone whose ever had that happen can testify to the unpleasant results, including the stomach pain, bloating, diarrhea, and other symptoms. Currently, there aren't too many options for celiacs who are exposed to small amounts of gluten, especially for those exposed on a regular basis. A team of researchers recently set out to assess changes in the ratio of villus height to crypt depth in celiac patients exposed to 2g of gluten per day for 6 weeks, as part of a study on IMGX003 (Latiglutinase). On behalf of theCeliacShield Study Group, the research team included Joseph A. Murray; Jack A. Syage; Tsung-Teh Wu; Chaitan Khosla; and Jennifer A. Sealey-Voyksner. They are variously affiliated with the Mayo Clinic, Gastroenterology and Hepatology in Rochester, MN; the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN; ImmunogenX, Inc., Newport Beach, CA; the Boston Biostatistics Research Foundation, Framingham, MA; Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland; and Stanford University, Stanford, CA. The team administered the double-blind, placebo-controlled gluten-challenge as part of a Phase 2 trial to assess the safety and efficacy of a 1,200 mg dose of IMGX003 in celiac patients exposed to 2 g of gluten per day for 6 weeks. The team used ANCOVA to assess progress toward their main endpoint, which was a change in the ratio of villus height to crypt depth (Vh:celiac disease), along with secondary endpoints, which included densities of intraepithelial lymphocytes (IEL) and symptom severity. Tertiary endpoints included serology and gluten-immunogenic peptides (GIP) in urine. Forty-three out of fifty randomized patients completed the challenge. Twenty one patients received IMGX003, while twenty-two received a placebo. The results showed that IMGX003 reduced gluten-induced intestinal mucosal damage and symptom severity in celiac patients on a six week gluten challenge of 2 grams per day. Drugs like IMGX003 could potentially play a role in receding symptoms and gut damage in people with celiac disease who are exposed to low amounts of gluten, especially through accidental exposure. Still, we've seen promising drugs come and go, each falling by the wayside when they failed to deliver in clinical trials. Stay tuned for more on this and related stories. Read more at gastrojournal.org
  6. Celiac.com 07/26/2022 - Previous drugs designed to induce tolerance to gliadin have met with failure. Will the latest effort fare any better? In people with celiac disease, gliadin-specific T cells drive an adverse immune response to gluten peptides, which can cause symptoms, long-term gut damage, and other related conditions. Currently, the only treatment for celiac disease is a gluten-free diet. A new drug, KAN-101, designed to treat celiac disease by inhibiting a key celiac disease biomarker, has received fast track status from the FDA ahead of Phase 2 Trials slated for the second half 2022. Designed by Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, KAN-101 has been found to be safe, well-tolerated, and to provide the proper immune responses. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. The Phase 1, randomized, double-blind, placebo-controlled trial enrolled a total of 41 individuals with celiac disease on a gluten-free diet in both single-ascending dose (SAD) and multi-ascending dose (MAD) cohorts. Findings from the Phase 1 trial showed that treatment with KAN-101 was safe and tolerated, and successfully reduced T cell responses following gluten challenge. The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of KAN-101, with secondary endpoints to assess KAN-101 serum concentrations and pharmacokinetics. Additional end points include the assessment of cytokines critical to both innate and adaptive immunity, T cell responses, and other serum cytokines and celiac disease symptoms. Patients who recieved KAN-101 experienced dose-dependent reductions of gluten-induced plasma IL-2, a cytokine that is elevated in celiac patients after gluten ingestion, and which reflects severity of acute symptoms. Patients who received the 0.6mg/kg dose experienced statistically significant reductions of IL-2, compared to other groups Administration of KAN-101 did not increase gut-homing CD8 T cell responses after gluten challenge, an indicator of immune response to gluten exposure in patients with celiac disease. Stories about new drugs designed to induce tolerance to gluten always cause great excitement within the celiac disease community. However, previous drugs designed to induce tolerance to gliadin have met with failure. Will the latest effort fare any better? Stay tuned for more as KAN-101 moves into its Phase 2 trial later this year. Read more at Businesswire.com
  7. Celiac.com 07/09/2019 - Everyone in the Celiac community has read the press release about ImmusanT stopping the Phase 2 clinical trial of their drug Nexvax2. The drug was going to modify the immune system to ignore gluten. The hope was no more worries about cross contamination! However, in late June, ImmusanT issued a press release stating, "Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo." Wait what? Let's go back a bit and talk about my experience in the clinical trial. I was in the Nexvax2 clinical trial. It consisted of five phases. The first phase was screening where they got all of your medical records that confirmed a celiac diagnosis and a gluten challenge. The gluten challenge was drinking a nasty gluten drink with the equivalent of 2 slices of bread and to evaluate your reaction and confirm that it was violent enough. The second phase involved updosing. We had to go to the center twice a week for six weeks to receive dose increase injections of the medicine. (I'm going to refer to the test drug as medicine - I don't know if I got Nexvax2 or placebo, but it's just easier to say medicine.) During this phase, I did experience some side effects. Occasionally I would be exceptionally tired or have an upset stomach. It was not bad and nothing that couldn't be managed with a nap and acetaminophen. The third phase was maintenance dosing. We had 10 weeks of bi-weekly self injections of the full dose of the medicine. The fourth phase was the food challenges. The fifth stage was post study testing. Last time I wrote about my experience, I was all the way into self-injections. I was given 20 pre-filled auto-injectors. I was given a schedule and a log to note when and where I injected. All of these shots went into my stomach. My abdomen was divided into 4 quadrants at my belly button - upper right, upper left, lower right, and lower left. I rotated where the shot went into my abdomen. They didn't hurt at all. I also noted the date, time, and whether or not I received the full injection. During this time, I never felt better. My energy levels were up. My weight was dropping without even trying. I was sleeping better. I was exercising better. I had normal bowel movements—which I haven't had in over 10 years—long, soft, well-formed just perfect. Dr. Oz would be proud. All of my celiac symptoms went away. It was like I was normal. This was a very, very good time for me. At week 6 of the 10 maintenance doses is when the food challenges began. There were three food challenges. In the three challenges, one challenge would be gluten, one challenge would be placebo, and the third would be of their choice, either gluten or placebo. So, I could potentially get gluten twice or a placebo twice. For the first challenge they brought out a big white box with my name on it. Inside were three smaller boxes labelled 1, 2, and 3. The smaller boxes contained a shaker bottle, water, and the powder that could be gluten or placebo. If it's gluten, it has the equivalent of two slices of bread. To start the test I had five minutes to consume the drink. This part was mentally challenging for me. In the first phase of the study, I knew I was getting gluten. I could prepare. I knew I was going to be sick and was doing this on purpose for science. That I could handle. This time I didn't know whether I was getting gluten or not. It is mentally tough to not know what you are getting. What happens if I react? What happens if I don't react? Does that mean this is a placebo? Does that mean I got a placebo instead of the medicine? What if I got the drug and I still react? Am I an outlier? What does that mean for the study? All of these things were going through my head as I was mentally preparing to drink the beverage. I cannot explain how challenging it was to drink that drink with the time pressure, not knowing what would happen. The first challenge went well. No reaction. I was a little nauseous but nothing like my first trip down the gluten road. All was well. It would be two weeks until the next challenge. Here's where things go a little sideways. I had to go to California between the first food challenge and second food challenge to help a relative who was recovering from a stroke. I packed my study medication, got on a flight, and flew out to the West Coast. Getting the auto-injectors through security was easy with my doctor's note, as well as the frozen ice packs needed to keep the Nexvax2 cold. On my first day in California I woke up with pink eye and a terrible cold. Off to urgent care I went for medicine because I can't risk giving my relative pink eye or a cold. I got pink eye medicine and amoxicillin. I was in California for about a week and planed to fly home the following Tuesday. I finished the antibiotic on Tuesday, and did my injection on Wednesday, per the protocol. Thursday I did the food challenge. This second challenge did not go well. I threw up about an hour after drinking the food challenge drink. That stunk. But I will say this. When I drank the gluten drink at the beginning of the study, I was sick for a week. On the couch with extreme exhaustion, gastrointestinal distress, and just general yuckiness. When I woke up on Friday, I didn't feel bad. I felt quite good. The change between feeling bad for a week and being able to bounce back from a glutening was glorious. Not all that is good, can stay good. At about 2:45 that afternoon, my left ring finger became exceptionally itchy, red, and started to swell. I was on my way to pick up my kids from school and stopped to buy some Benadryl cream for my finger. As the day progressed, my finger started to swell and continued to be itchy. By 5 that night, the swelling and itchiness had spread to my palm and my right hand was beginning to itch. By 7 that night both of my hands were so swollen I couldn't make a fist. I had been drinking Benadryl like it was wine and it was not making a dent in the itch or the swelling. By 9 that night, my neck started itching. By the time I left for the Emergency Department at 11 that night, my hands were so swollen I couldn't bend my fingers and both my hands and my neck were incredibly itchy. After a few hours in the waiting room, I saw the doctor and he said I was having an allergic reaction. He contacted the study doctors confirming that I was having an allergic reaction. They said to make sure I was safe, give me whatever medication was needed, and don't worry about the study. My health and safety came first. I was given IV Benadryl and steroids and sent home. One of the reasons someone was not going to be able to be in the study was taking an oral steroid 6 months prior to the first injection. I was lying in the ER four injections from the end of the study realizing that my participation in the study may be over. The ER doctor did not know what could have caused the reaction and wouldn't hazard a guess, but did say that an allergic reaction to amoxicillin could start several days after stopping amoxicillin. I was told to not do any more self-injections until further notice. After a few days, the swelling in my hands went down and returned to normal. There doesn't seem to be any long term effects from this episode. Over the next few days, the study doctors and the people from ImmusanT talked about my case. They decided for my safety that I should be removed from the study. I felt like my rocket engine propelling me toward a cure just flamed out. But they were right. We don't know why I had a reaction and we could not risk me having another, potentially more severe reaction next time. I had to go to the study center to return the four remaining auto-injectors, do final blood testing, and final testing for the study. It was a very sad day for me. I felt like a failure. My body failed and there was nothing I could do about it. I still feel like that study is unfinished and it makes me sad to write my story. Reading the notice that the Nexvax2 trial was terminated early was another blow to me. It was even worse knowing how good I felt on the medicine. It was worse knowing that after the food challenge my reaction was totally different than the first gluten challenge. I believed it worked for me. I feel like I failed, not the medicine, by having an allergic reaction. So when they stopped the trial, I felt like a failure again. Looking ahead. I hope they look at the data and can find something good in it. I hope they are able to see that the daily journal of side effects went to almost zero when I was on the medicine compared to symptoms almost daily before starting the medicine. I hope they can retool the study to maybe not test against such a high gluten dose. I mean since when is cross contamination the gluten equivalent of 2 slices of bread? Normally, if we get glutened, it is a much smaller amount that makes us sick. Heck, the FDA says anything more than 20 parts per million causes damage, so maybe they could test against a smaller amount of gluten. I think that's where I would look if I were the ImmusanT scientists. I also have to remember that Nexvax2 is only one of several drugs that are currently in clinical trials for celiac disease. While I hope to see Nexvax2 again, there are other drugs with real potential. I had hoped Nexvax2 was a cure, but I would be temporarily satisfied with something that allowed me not to worry about every single morsel of food I put into my mouth making me sick. As a side note, I write a blog and talk about clinical trials all the time. I found a celiac study looking for healthy volunteers. I had several healthy parents of celiac kids asking for more information so they could volunteer to help propel the quest for a cure forward. The idea that these parents are willing to put themselves in a clinical trial in order to help their children has always demonstrated the quiet hope for a cure that I think we all feel. I firmly believe the cure for celiac disease will be here in the next 10-15 years. I'm not sure what it may look like but I do know this—each person with celiac disease and has the ability to volunteer for a clinical trial should. It is worth the time and effort and will potentially pay big dividends in the future for all of us. Science can't advance without some of us putting our bodies on the line. In closing, my clinical trial ended in March. I believe my body is working better today than it did before the trial and it's now July. My old celiac body is creeping in, but it still isn't as bad as it was before the trial.

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  9. Celiac.com 03/22/2019 - I'm going to talk about my journey through the Nexvax2 trial. It is a clinical trial to study the effectiveness of this drug to prevent mucosal damage due to cross contamination. There are 4 phases to this trial - Screening, Updosing, Maintenance, and Post-Study. Each phase has different requirements from the patient and different goals. Screening for the Nexvax2 Clinical Trial I found out about the Nexvax2 trial from my sister. Her job involves keeping up with medical stocks. She saw that ImmusanT had started their clinical trial - a double, blind, placebo controlled study for an injection to retrain the immune system to stop recognizing gluten as a foreign invader. It works similarly to allergy shots desensitizing the immune system to gluten. I looked up the trial at ClinicalTrials.gov and made a phone call to the nearest location. There were 35 trial locations across the US and a couple of locations in Australia. I live in Atlanta and the closest locations were in Jacksonville, FL or Nashville, TN. I decided to call Nashville because it is only a 4 hour drive compared to the 6 hour drive to Jacksonville. I called and talked to Nurse Ratchet (not her real name, to protect the innocent). She explained that it was a long trial, about 7 months, and that I had to be in Nashville twice a week for six weeks. She said she would send me the patient disclosure and she would answer any questions I had when I was ready. She also said that I needed to be able to prove my Celiac diagnosis with both positive blood work and positive endoscopic biopsy. I would have to be on a gluten free diet for 12 months. I would also have to carry the DQ2.5 gene and do a gluten challenge. I will also have to decide if I'm going to participate in the optional endoscopy portion of the trial. The twice a week for six weeks thing threw me for a loop. That would be a big time commitment, hard on my family, and very expensive. I wasn't sure we could do this. As my husband and I review the disclosure document, there is a lot of information to take in. One of the requirements to get in the trial is having the DQ2.5 gene. I've had genetic testing done several times and knew I had one copy of DQ2.5. In reading the documents, if you have one copy of DQ2.5, you have a 1 in 2 chance of receiving the drug. If you have two copies of DQ2.5, you have a 2 in 3 chance of receiving the drug. Nexvax2 does not work for those with DQ8. According to research, over 90% of people with Celiac have DQ2.5. So, I have 50/50 chance of getting the medicine and I have to be in Nashville twice a week for six weeks. That is a big time commitment for a 50/50 chance at the medicine. We decide it isn't worth it. Until, I talk to Nurse Ratchet and she confirms that if I get placebo in the trial, I will get the medicine when the drug is approved. Now we are talking. I have a 100% chance of getting the medicine - either sooner or later. We decide to go for it!! I find my medical records that demonstrate I have Celiac disease, send them to Nurse Ratchet and we schedule my first appointment - November 1. The first appointment lasts for 8 hours. The initial testing involves blood work, urine tests, EKG, physical, and do a gluten challenge. This is going to be a very long day. The gluten challenge is the most worrying part. I will have to ingest a lot of gluten - the equivalent of two slices of bread. They will gauge my reaction after the drink and monitor me for the next few hours. I have 5 minutes to consume the unflavored gluten drink. At this point, you might be thinking why would I purposefully ingest gluten? I'm poisoning myself. I know I'm going to be sick. What sane person does this? A person that is tired of being sick. I'm tired of worrying about food all the time. If this is what I have to endure to ensure that I can get better, I'm in. After consuming the gluten poison, we wait. After about an hour, I start feeling fatigue - mind numbing fatigue. The kind of fatigue that you just want to lay in a dark, cool room under a blanket thinking of nothing. At hour two, the vomiting starts. I throw up twice in about a 30 minute span. My reaction is severe enough to qualify into the study. But now I have to start to deal with the consequences of glutening myself. Once the testing is over, I get on an airplane and fly home. That was a miserable flight. I won't bore you with the unpleasant details, but know the flight was not good. I'm miserable the whole week after the gluten challenge. Fatigue, brain fog, gastrointestinal distress, and just feeling bad is what I dealt with for a week. A full seven days of being completely incapable of living my life in any meaningful way. It was a week of watching TV, ordering food in, and just breathing. Eventually I get better. When the malaise lifts, it lifts like opening a curtain to reveal bright sunshine. I am finally better. We opted to do the optional endoscopy study. I had to go back to Nashville at the beginning of December for the endoscopy. The flight, fasting, and doing the test in the early afternoon did not make for a great day. Really, it was a very bad day. Normally, I don't struggle with endoscopies. Normally I simply do the endoscopy and go eat a big meal and am fine for the rest of the day. This time I slept from about 1 hour before my procedure, through the procedure (they gave me good stuff to help with that), and then on the 4 hour car ride home. I slept a lot that day. Then we wait. We have to wait for all of the blood tests and endoscopy results. About a week after the endoscopy, Nurse Ratchet confirms I have made the cut. I'm in the trial! During the trial, I had to promise to not start taking any supplements or medicine without letting them know. I had to put a card in my wallet that said that I was in a clinical trial and it not give me medicine until the doctor called this number. There are also surveys you have to fill out on the little device they give you. You have to do them every night and they must be completed between 6 pm and midnight. Most days it is two surveys - one asking about symptoms and one about your bowel movements. The one about the symptoms asks you to rate how your symptoms are on a scale of 1 to 10. The other asks how many bowel movements you've had and tell what they were like on the Bristol Stool Chart. In the whole 6 month period you are only allowed to miss 4 surveys. I set two alarms to remind me - one at 6 pm and one for 8:30 and carried the device with me at all times so I could do the survey when ready. We have completed phase 1 - the screening phase. Now, it is time for phase 2 - updosing. Updosing: Reaching the Nexvax2 Dosage In reading the consent document, updosing is important because when they tried to give people the full dose of the medication in Phase 1 trials the side effects were too dramatic and people dropped out. The main side effects of this medicine are headache, fatigue, and diarrhea. Those side effects are the same for me when I get cross contaminated so I wasn't worried about the side effects. On the first injection day, I had to be in Nashville for for 4 hours so medical personnel can watch you and make sure you don't have an allergic reaction. They use a small insulin needle to inject the drug, so it doesn't hurt. The shot does have to go into your belly, so that's a little weird. I would have preferred it in my arm! The first dose is a very small dose of the medicine with a lot of saline. Over time the amount of medicine increases and saline decreases until about half way through. About half way through the up dosing, you get the medicine straight, no chaser (no saline). The updosing is not a challenge. I did have periods where I did experience side effects. Occasionally, I had problems with fatigue and headache, but it did not affect my life or how I functioned. There was one time, specifically, I had an issue with fatigue and headache. This was a bad headache. It did not let up with ibuprofen or acetaminophen alternating every 4 hours. It was about half way through the updosing and it lasted for about 3 days. Then it lifted. Everything was gone and I was back to feeling good. Also over the course of this study, I've had periods of flushing. Flushing where my face and neck would turn bright red and feel like they are on fire. When this happens, I would take a Benadryl and go to bed. My mom thinks it is menopause, but that's just for old ladies, not me. The hardest part about updosing was the travel and the grind of going twice a week. I also was doing this in December and January. December and January are hard because of the holiday season, but we also have 3 family birthdays during the span of this period. But we made the best of it and one time the whole family came with me and we spent a couple of days in Nashville. Maintenance Dosing Once updosing is complete, maintenance dosing starts. Maintenance dosing is 10 weeks of twice weekly injections of the full amount of medicine. They are self-injections. The injections need to stay refrigerated, so I have this super cool cooler in my fridge. TSA didn't even flinch when I came through security! I got 20 auto-injectors for the ten weeks of twice weekly injections, alcohol swabs, and a log book. I had to log the date, time, and location of my injection. You inject in a pattern in your abdomen- upper right, lower left, lower right, and finally upper left. I will say this phase was a bit of a relief for me. It meant less travel and just kind of coasting along. Until, the food challenges - duh duh duh daaaaa! The food challenges are to see if the medicine is working. There are three food challenges - one gluten, one placebo, and one either gluten or placebo. So, you will get gluten at least once but not more than twice. The challenges are spaced two weeks apart. The procedure for the food challenge is much the same as at the initial gluten challenge. They do the normal stuff - weight, blood pressure, and temperature. Then they pull out the big white box with my name on it. Inside the big white box is three smaller white boxes. They all are sealed. These are my food challenge boxes. She takes the first box out and opens it. It contains a shaker bottle, a box of water, and two packets of powder. One packet of powder is flavoring and the other is the test material. She mixes the drink per the instructions and I have 5 minutes to consume this beverage. The drink is pink and overly sweet. (At the gluten challenge, there was no flavoring. Just straight up gluten.) The test drink tastes terrible, but I consume the beverage. Then we wait. We wait to see if my body reacts the same or differently to the initial gluten challenge at the start of the trial process. It is just a waiting game. They said I could keep the shaker bottle we mix my food challenge drinks in. They are really nice shaker bottles. I cannot keep them. I truly never want to see those shaker bottles again. Those shaker bottles are my enemy and I want no part of them. Those shaker bottles make me sick and I don't want them. I've done two food challenges to this point. One I had no reaction and the other I reacted. I threw up, but I wasn't tired for a week. I was tired for 24 hours. So, that's where we are. We are working through the process. I have no idea if I'm getting the medicine or placebo. I don't know if I got gluten at any of the food challenges. That is what makes this so hard. The mental gymnastics of am I getting the medicine or am I not - is very, very challenging. It can consume all of your thoughts if you let it. Post Trial I haven't gotten to this part yet, I'm still in the food challenges phase of the study. The final part of the study means I will turn in all my used autoinjectors and boxes, log from where and when I did injections, and be turned loose into the world with my new found protections against cross contamination. It will be exciting. Conclusion I don't know if I got medicine or placebo. I may never know for sure. I have guesses and theories but that is all I have, which makes this really hard mentally. It is hard to have symptoms or not have symptoms and not know if you are getting the medicine. But I think those mental gymnastics are not helpful. I went into this hoping for a cure with the expectation that I would not receive the medicine and would be sick quite often. I haven't been any more sick than I would have been living my life normally, so that's a good thing. Some people argue that they never want a medicine for Celiac. They don't want a vaccine or any part of anything from Big Pharma. They say putting gluten in your body is inflammatory and bad for everyone. They say Roundup causes Celiac disease and if you eat organic all will be fine. Here's my answer - If you don't want the medicine, don't take the medicine. It isn't required and nobody will force you to take it. But this disease has impacted my life so dramatically, I'm willing to try a new medicine to alleviate the symptoms. This disease has affected my family, my health, my social life, and my ability to vacation among other things. Even if this or any other medicine is approved, I'm not sure I would return to a full gluten diet. I don't mind a gluten free diet. I mind the constant vigilance I have to have all the time while eating three meals a day. I mind that many labels are not accurate when they say an item is gluten free, but it has barley or rye in the product. I mind that I can't just take a road trip with my family without carefully planning each meal along the route so that I'm sure I can eat safely. I mind that I have to ask every waiter 15 million questions before ordering at a restaurant in order to get a meal that is safe and even then I'll probably be sick. I mind that I can't engage in normal social activities, like sharing a meal with someone, without doing research on where we can go or just having to bring my own food. I mind not being able to have a scoop of ice cream with my kids at the beach in the summer. I mind a lot of things that this disease has imposed on me. I believe most other Celiac sufferers endure the same hardships I do in finding safe foods. So, finding a cure or at least something that makes our lives better is a worthy cause that should be encouraged and cheered. Maybe others don't share my struggles and that is great. Maybe they are happy never going to dinner or out with friends. I'm not. I want a normal life or even some semblance of one where I can do the most basic and ancient ritual of society - sharing a meal without fear. So, take the medicine or not - it's up to you, but don't knock the people who want it.
  10. Celiac.com 06/20/2018 - Currently, the only way to manage celiac disease is to eliminate gluten from the diet. That could be set to change as clinical trials begin in Australia for a new vaccine that aims to switch off the immune response to gluten. The trials are set to begin at Australia’s University of the Sunshine Coast Clinical Trials Centre. The vaccine is designed to allow people with celiac disease to consume gluten with no adverse effects. A successful vaccine could be the beginning of the end for the gluten-free diet as the only currently viable treatment for celiac disease. That could be a massive breakthrough for people with celiac disease. USC’s Clinical Trials Centre Director Lucas Litewka said trial participants would receive an injection of the vaccine twice a week for seven weeks. The trials will be conducted alongside gastroenterologist Dr. James Daveson, who called the vaccine “a very exciting potential new therapy that has been undergoing clinical trials for several years now.” Dr. Daveson said the investigational vaccine might potentially restore gluten tolerance to people with celiac disease.The trial is open to adults between the ages of 18 and 70 who have clinically diagnosed celiac disease, and have followed a strict gluten-free diet for at least 12 months. Anyone interested in participating can go to www.joinourtrials.com. Read more at the website for Australia’s University of the Sunshine Coast Clinical Trials Centre. Source: FoodProcessing.com.au
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