• Join our community!

    Do you have questions about celiac disease or the gluten-free diet?

  • Ads by Google:
     




    Get email alerts Subscribe to Celiac.com's FREE weekly eNewsletter

    Ads by Google:



       Get email alertsSubscribe to Celiac.com's FREE weekly eNewsletter

  • Member Statistics

    77,651
    Total Members
    3,093
    Most Online
    Kitty11
    Newest Member
    Kitty11
    Joined
  • 0

    Does New Drug Promise Cure for Celiac Disease?


    Dr. Vikki Petersen D.C, C.C.N


    • Journal of Gluten Sensitivity Winter 2013 Issue


    Image Caption: Image: CC--Jonathan Silverberg

    Celiac.com 06/23/2017 - Dr. Alessio Fasano from the University of Maryland's Celiac Research Center published a paper in Clinical and Developmental Immunology last month. It focused on a new drug developed by Dr. Fasano that has shown promising results in both animal and human trials. But is this the 'magic pill' that will cure celiac disease and gluten sensitivity? Let's take a look.


    Ads by Google:




    ARTICLE CONTINUES BELOW ADS
    Ads by Google:



    The new drug, formerly called AT1001 but now renamed Larazotide Acetate, is a zonulin inhibitor. For those who have never heard the word 'zonulin', you might think it's a term from a science fiction movie. But zonulin is the protein that causes the 'gates' or openings between the cells making up the lining of the small intestine to open and close. These openings are called tight junctions and when zonulin gets excessive, a leaky gut ensues.

    Dr. Fasano has made great inroads to prove that a leaky gut is a problem that must be handled with gluten intolerance. The leaky gut perpetuates gluten's negative impact on other parts of the body. It can also initiate autoimmune disease.

    One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter.

    So, the drug Larazotide Acetate is a zonulin inhibitor. Now that we've reviewed what zonulin does as regards opening the gates, the purpose of inhibiting its action should make sense. How well does it work? In the recent human trials that were double-blind, randomized placebo-controlled (the best type of study, but I would expect no less from the stellar Dr. Fasano), a gluten exposure created a 70% increase in intestinal permeability (leaky gut) in 57% of the placebo group but only 28.6% of the patients receiving the drug (4 out of 14 patients) experienced such increased permeability.

    Further, gastrointestinal symptoms were significantly more frequent among patients of the placebo group as compared to the group that received the Larazotide.

    A pro-inflammatory substance known as interferon gamma was also evaluated. This is manufactured by the body when a specific foreign/toxic agent is recognized by the body's immune system. As expected, levels of interferon gamma increased in 4 out of 7 of the placebo patients (57%) but only 4 out of 14 larazotide patients (28.6%) saw any increase.

    The good news is that this drug seems well tolerated and it does reduce the leaky gut response that gluten ingestion normally creates. Further, it also reduces the percentage, by about half, of the production of interferon gamma. These are all excellent results.

    But, and it's unfortunately a very big 'but', we have a very long way to go before such a drug would be useful for your typical celiac or gluten sensitive patient. Will Dr. Fasano and his team be able to tweak this drug such that it functions at a higher level of efficacy? I certainly hope so, but let's analyze exactly what this drug does in its present state:

    • The drug still resulted in almost 30% of the patients experiencing a 70% increase in permeability (leaky gut) – Not good.

    A highly pro-inflammatory (this means that it creates degenerative disease) substance known as interferon gamma was also produced in nearly 30% of the drug-consuming patients tested – Not good.

    Leakiness, or the passage of negative substances through cells is not affected by this drug – Not good.
    Of course on the plus side, over 70% of those tested DID have a very good result with apparently no untoward side effects – Very good.

    At what point is the efficacy high enough that you'd be willing to subject yourself to a possible reaction? Do realize that any gluten ingested increases your chance of disease, chief amongst them cancer and autoimmune disease. Is there a level of function of the drug that you would chance taking it? Is it 90%, 99%? Does any drug ever get that good?

    Well, as a big fan of Dr. Fasano's, I would say that if anyone can do it, he and his team can. But at the same time, I cannot help but think of all the other drugs I have encountered. As 'wonderful' as they sometimes seem initially, they almost always fall from grace when some horrible side effect is realized.

    Would I guinea pig my own health that I've fought so hard to regain? Would I recommend taking such a chance to my children just so that they could consume some white flour product? I don't think so.

    How about you? What do you think? If the drug were available right now at its efficacy of 71%, would you take it and hope you weren't in the 29% for whom it didn't work? I'd love to hear your thoughts.

    If you are wondering if you're gluten intolerant or know that you are but still aren't enjoying good health, consider calling us for a free health analysis: 408-733-0400. We are here to help! Our destination clinic sees patients from across the country and internationally so you do not need to live locally to receive assistance.

    To your good health!

    Reference:

    • Alessio Fasano, Clinical and Developmental Immunology, Published online 2012 October 10. "Novel Therapeutic/Integrative Approaches for Celiac Disease and Dermatitis Herpetiformis."

    0


    User Feedback

    Recommended Comments

    Guest Lori Gunter

    Posted

    I was one that was in the clinical trial in Orange County, Ca. I am glad that someone is trying to help us with Celiac. I have been gluten free not for over 15 years and have seen big changes with doctors, restaurants and the public. I hope everyone takes celiac as serious as I do!!

    Share this comment


    Link to comment
    Share on other sites
    Guest Michael

    Posted

    There's no way I would try a drug with 30% ineffectiveness. There's no way I would allow a "vaccine" with gluten peptides to be injected, and the one reported on last month had a 30% adverse event rate: that means increased autoimmunity. In my education and experience, in regards to help for celiac patients, the drug companies are never going to equal medical cannabis, which protects the brain, modifies B-cell and T-cell activity, helps the immune system to recognize self, and upregulates occludin, which counters zonulin. Not only that, cannabis stops the growth of cancer in five different ways, including helping the immune system recognize cancer cells as non-self.

    Share this comment


    Link to comment
    Share on other sites
    Guest Keith MacFarland

    Posted

    Great article (as always, you write beautifully) but I've seen no real movement on any drug or cure for the past 8 years. It's as if we are just "stuck" at phase 2b or less on all solutions and at the speed of this research I will long be dead before I will ever see a cure or substance that allows me to eat gluten safely again. When my twins who are celiac are out on their own I will likely go off my diet.. quality of life is nil when I'm forced to eat at the same restaurants and eat the same food all the time..

    Share this comment


    Link to comment
    Share on other sites
    Guest Marie

    Posted

    I think this drug is good for any other disease where cell permeability is involved, other than celiac. I still believe genetic manipulation is the only way to cure celiac disease.

    Share this comment


    Link to comment
    Share on other sites
    Guest Adair hallman

    Posted

    My husband has severe celiac and my son he was eight and has almost died twice. The better part of a leaky got my husband, and he is beginning to have bipolar symptoms...please we would love to try the Zonulin!

    Share this comment


    Link to comment
    Share on other sites
    Guest Chris M

    Posted

    I'm excited, especially for the ones who suffer terribly when ingesting gluten. I myself was diagnosed with celiac disease 15 years ago, although if I have a half of a roll once or twice a year or drink a Corona Light occasionally I never have any reactions. Not sure why. Nothing ever seems to bother me but I still continue to do quite a good job staying away from gluten. This article gives me hope that I may be able some day to enjoy the food I love again.

    Share this comment


    Link to comment
    Share on other sites
    Guest Daniel S

    Posted

    70% is good, mainly for people that have issues with Gluten but are non celiac, how long to hit the shelves?

    Share this comment


    Link to comment
    Share on other sites
    Guest Laura

    Posted

    Answer to would I try it: NO! I have been devastated by celiac disease and associated food toxicities. 2009 was the year when the public first heart about the gluten protein. Chronic & severe diarrhea following meals was too elusive for a certain diagnosis. A gastroenterologist publicized the relationship between celiac and its cross-mediators/cross-reactors: yeast, dairy, egg and coffee. Additionally, symptomology occurred with: preservatives and artificial flavoring. Through trial & error, I discovered other foodstuffs that create a toxic effect: flower and seed oils. Research of the oil extraction processed revealed that extreme heat and chemicals creates toxins. This too contributed to the GI effect. Long term & repeated exposures resulted in malnutrition and neurological disturbances to the point of Near Death by Gluten. Hybridization of wheat has occurred since the 1950's. Chemical analysis revealed the gluten ratio has increased by 17 times since 1960. Six slices of today's wheat bread have the gluten equivalent of 102 slices of the 1960's version. There is no reversal of this disease. This disease effects hundreds of thousands of people and it DID NOT HAVE TO HAPPEN! Is it any surprise that GI cancer has increased substantially in the US?

    Share this comment


    Link to comment
    Share on other sites

    Very good information, but I too would not risk the chance of gluten exposure. The diet is not hard, so why would I?

    Share this comment


    Link to comment
    Share on other sites
    Guest Janice Messer

    Posted

    I was diagnosed with non tropical Sprue (Celiac disease) over 43 years ago. I would not take the pill and see no need to. There are so many opportunities now to eat gluten free. Yes, I have had times when I didn't know gluten was in something, but those times are now fewer and less drastic, thank God.

    Share this comment


    Link to comment
    Share on other sites
    Guest L Maureen

    Posted

    I can't even finish this article, because the writing is so terrible. I can't understand what the author is trying to say. For instance, this passage makes no sense: "One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter."

    Share this comment


    Link to comment
    Share on other sites
    Guest David Quig, PhD

    Posted

    I'm not sure why you focus so much on the lack of effect of the compound on transcellular transport- very important for water/electrolyte balance as well as the uptake of other small molecules...why would one want to mess with that? I too very much appreciate Dr. Fasano's work and enthusiasm, but do agree that 70% efficacy doesn't cut it and strict avoidance is pretty much the only sure way to go (coming from a former senior pharmacologists).

    Share this comment


    Link to comment
    Share on other sites
    I'm excited, especially for the ones who suffer terribly when ingesting gluten. I myself was diagnosed with celiac disease 15 years ago, although if I have a half of a roll once or twice a year or drink a Corona Light occasionally I never have any reactions. Not sure why. Nothing ever seems to bother me but I still continue to do quite a good job staying away from gluten. This article gives me hope that I may be able some day to enjoy the food I love again.

    There are celiacs that are asymptomatic but their insides show the damage. My uncle is like this and does the same. My friends husband died because of lymphoma caused by celiac. Be safe and if you eat the odd roll and carona get your gut checked every year.

    Share this comment


    Link to comment
    Share on other sites
    Guest Olena

    Posted

    I can't even finish this article, because the writing is so terrible. I can't understand what the author is trying to say. For instance, this passage makes no sense: "One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter."

    That's what I thought!

    Share this comment


    Link to comment
    Share on other sites
    Guest Dunnyveg

    Posted

    This is one drug I'd like to be able to take, even if I were never to eat gluten. I've noticed that even walking by the bakery in grocery stores, or even at times the bread section, it's enough to give me a headache. Also, I live around wheat fields. Since farmers aren't going to quit growing wheat to keep me happy, I can only hope and pray this drugs works, and becomes available at a price that won't make cocaine and heroin dealers envious.

    Share this comment


    Link to comment
    Share on other sites
    Guest Laura

    Posted

    This is one drug I'd like to be able to take, even if I were never to eat gluten. I've noticed that even walking by the bakery in grocery stores, or even at times the bread section, it's enough to give me a headache. Also, I live around wheat fields. Since farmers aren't going to quit growing wheat to keep me happy, I can only hope and pray this drugs works, and becomes available at a price that won't make cocaine and heroin dealers envious.

    When I was a little girl in the 1950's, I'd grocery shop with my mother. When we traveled down the bread isles we would stop to smell the sweet odor of the baked breads. Over the last 7 years I have to cover my nose and mouth while moving rapidly down to the end of the isle. What a strong STENCH! The breads REEK, so FOUL smelling!

    Share this comment


    Link to comment
    Share on other sites

    Hi Dr Petersen, This is really interesting. I'm not a big fan of drugs to solve problems when diet and lifestyle will do that trick. But I realize being totally gluten free can be difficult and annoying at best!

    Share this comment


    Link to comment
    Share on other sites


    Your content will need to be approved by a moderator

    Guest
    You are commenting as a guest. If you have an account, please sign in.
    Add a comment...

    ×   Pasted as rich text.   Paste as plain text instead

      Only 75 emoji are allowed.

    ×   Your link has been automatically embedded.   Display as a link instead

    ×   Your previous content has been restored.   Clear editor

    ×   You cannot paste images directly. Upload or insert images from URL.


  • Ads by Google:

  • About Me

    Dr. Vikki Petersen, a Chiropractor and Certified Clinical Nutritionist is co-founder and co-director, of the renowned HealthNow Medical Center in Sunnyvale, California. Acclaimed author of a new book, "The Gluten Effect" - celebrated by leading experts as an epic leap forward in gluten sensitivity diagnosis and treatment. Dr. Vikki is acknowledged as a pioneer in advances to identify and treat gluten sensitivity. The HealthNOW Medical Center uses a multi-disciplined approach to addressing complex health problems. It combines the best of internal medicine, clinical nutrition, chiropractic and physical therapy to identify the root cause of a patient's health condition and provide patient-specific wellness solutions. Her Web site is:
    www.healthnowmedical.com

  • Popular Contributors

  • Ads by Google:

  • Who's Online   14 Members, 0 Anonymous, 668 Guests (See full list)

  • Related Articles

    Scott Adams
    Celiac.com 05/14/2000 - Scientists from the University of Maryland have discovered that people with the autoimmune disorder celiac disease have higher levels of the protein zonulin in their bodies. This discovery may ultimately lead to more insight into the causes of other autoimmune diseases, including diabetes, multiple sclerosis and rheumatoid arthritis. In people with celiac disease who eat gluten, which is found in wheat, rye and barley, an autoimmune reaction is set off that creates antibodies that end up attacking their intestines. This causes symptoms like diarrhea and abdominal pain, and may lead to long-term damage and a large host of other problems. Researchers at the University of Maryland have finally found the cause of this curious reaction: a protein in the body called zonulin.
    Zonulin is a human protein that acts like a traffic conductor for the bodys tissues by opening spaces between cells, and allowing certain proteins to pass through, while keeping out toxins and bacteria. People with celiac disease have higher levels of zonulin, which apparently allows gluten to pass through the cells in their intestines, which triggers an autoimmune response in their bodies. Until now, researchers could never understand how a big protein like gluten could pass through the immune system. According to author Alessio Fasano, M.D., people with celiac have an increased level of zonulin, which opens the junctions between the cells. In essence, the gateways are stuck open, allowing gluten and other allergens to pass. Further: I believe that zonulin plays a critical role in the modulation of our immune system...(f)or some reason, the zonulin levels go out of whack, and that leads to autoimmune disease. Ultimately these finding may help doctors understand the causes of other, more severe autoimmune disorders.

    Jefferson Adams
    Celiac.com 05/27/2008 - People with celiac disease know all too well that the only effective treatment at present is faithfully following a gluten-free diet. There’s been a lot of talk about various therapies and enzyme treatments that would allow people with celiac disease to return to a normal diet. Talk to anyone who suffers from celiac disease and they’ll likely have a personal horror story about a time when they had an unhappy episode of cross-contamination.
    So, the idea of a drug that would prevent such symptoms is appealing, and the goal, desirable. The chief cause of recurring symptoms in celiac disease is accidental gluten exposure, usually through cross-contamination. Cross-contamination doesn’t always mean food. Gluten is a common ingredient in many medicines and vitamins, and exposure in celiacs can cause diarrhea, weight loss, abdominal pain, anemia and oral ulcerations in the short-term, and myriad other problems in the long-run.
    The drug AT-1001 is a good example of how the realities are playing out on the front-lines of science. AT-1001 is an enzyme therapy that has promised some degree of protection from gluten exposure in people with celiac disease.
    A team of researches recently set out to assess the effectiveness of AT-1001 in preventing gluten from crossing the gut barrier by reversing the defective barrier mechanism. This required evaluating intestinal permeability between those exposed to gluten after taking AT-1001, those exposed without AT-1001, and control groups. The of intestinal function is done by gauging the absorption rates of various sugars.
    Early testing of AT-1001 showed some progress and a significant rate of protection of celiac patients exposed to wheat proteins. The research team looked at 86 subjects with celiac disease. The patients were divided into three groups. The first group was given placebo AT-1011 and challenged with gluten, the second group was given either active or placebo AT-1001, while the third group was given gluten and active AT-1001.
    After the first week, all subjects showed improvement, possibly due to closer adherence to a gluten-free diet. At three weeks, those given AT-1001 showed substantial improvement over the group given gluten and placebo AT-1001, including reduced intestinal permeability and fewer symptoms of gluten toxicity.
    The problem is that while AT-1001 shows a degree of promise, the results are so far underwhelming. The research team noted that the degree of improvement did not match the primary study. The results are, however, strong enough to encourage researchers to conduct a larger trial of AT-1001, which is currently underway.
    It’s important to remember that celiac disease is an immune disorder and no immune disorder has ever been fully cured. So, the idea of people with celiac disease being able to take a pill and head out for a night of pizza and beer without the standard celiac-related reactions is far-fetched at best. At best, such drugs would likely help to prevent cross-contamination, rather than conveying immunity to gluten proteins.
    Until then, stay tuned…best of luck with the gluten-free diet!
    Presented by Dr. Leffler at the 2009 Digestive Disease Week on Tuesday, May 20 at 10:45 a.m. Pacific Time in room 10, San Diego Convention Center.


    Jefferson Adams
    Celiac.com 05/29/2017 - Currently, a gluten-free diet is the only way to manage celiac disease. Can a celiac vaccine change that? One company thinks so. ImmusanT corporation has developed a therapeutic vaccine, Nexvax2, that is specifically designed to treat celiac disease. The vaccine is an adjuvant-free mix of three peptides that include immunodominant epitopes for gluten-specific CD4-positive T cells. The vaccine is designed to neutralize gluten-specific CD4-positive T cells to further antigenic stimulation.
    As part of their efforts to evaluate the vaccine, a team of researchers recently set out to investigate the efficacy of epitope-specific immunotherapy targeting CD4-positive T cells in celiac disease. Specifically, they assessed the safety and pharmacodynamics of the Nexvax2 vaccine in patients with celiac disease on a gluten-free diet.
    An article detailing the findings of their most recent effort, titled Epitope-specific immunotherapy targeting CD4-positive T cells in celiac disease: two randomized, double-blind, placebo-controlled phase 1 studies, appeared in the Lancet.
    The research team included Gautam Goel, PhD, Tim King, MBBChir, A James Daveson, MBBS, Jane M Andrews, MBBS, Janakan Krishnarajah, MBBS, Richard Krause, MD, Gregor J E Brown, MBBS, Ronald Fogel, MDCM, Charles F Barish, MD, Roger Epstein, MD, Timothy P Kinney, MD, Philip B Miner Jr, MD, Jason A Tye-Din, MBBS, Adam Girardin, BS, Juha Taavela, MD, Alina Popp, MD, John Sidney, BS, Prof Markku Mäki, MD, Kaela E Goldstein, BS, Patrick H Griffin, MD, Suyue Wang, PhD, John L Dzuris, PhD, Leslie J Williams, MBA, Prof Alessandro Sette, DrBiolSc, Prof Ramnik J Xavier, MD, Prof Ludvig M Sollid, MD, Prof Bana Jabri, MD, and Dr Robert P Anderson, MBChB.
    To assess the safety and pharmacodynamics of the vaccine in patients with celiac disease on a gluten-free diet, ImmusanT recently conducted two randomized, double-blind, placebo-controlled, phase 1 studies at 12 community sites in Australia, New Zealand, and the USA, in HLA-DQ2·5-positive patients aged 18–70 years who had celiac disease and were following a gluten-free diet.
    The goal of the study was to document the number and percentage of adverse events in the treatment period in an intention-to-treat analysis.
    The study enrolled a total of 108 participants from Nov 28, 2012, to Aug 14, 2014, in the three-dose study, and from Aug 3, 2012, to Sept 10, 2013, in the 16-dose study.
    Overall, 62 (57%) of 108 participants were randomly assigned after oral gluten challenge and 20 (71%) of 28 participants were randomly assigned after endoscopy.
    None of the study participants, investigators, or staff knew which patients received a given treatment; these details were known only by the study’s lead pharmacist.
    In the three-dose study, participants received either Nexvax2 60 μg, 90 μg, or 150 μg weekly, or placebo over 15 days; in a fourth biopsy cohort, patients received either Nexvax2 at the maximum tolerated dose (MTD) or a placebo.
    In the 16-dose study, participants received Nexvax2 150 μg or 300 μg or placebo twice weekly over 53 days; in a third biopsy cohort, patients also received either Nexvax2 at the MTD or a placebo. In both studies, about 5% of the participants reported were vomiting, nausea, and headache.
    Among participants given the MTD, four of eight subjects in the third cohort experienced adverse gastrointestinal treatment-emergent events; zero of three participants had adverse events in the biopsy cohort in the three-dose study, while five events occurred in five (63%) of eight participants in the first cohort, and three events in two (29%) of seven participants in the biopsy cohort of the 16-dose study.
    Those who received the vaccine at the MTD on either schedule showed no significant difference between average villous height to crypt depth ratio in distal duodenal biopsies, as compared with those who received placebo.
    In the 4-week post-treatment period, ascending dose cohorts underwent a further double-blind crossover, placebo-controlled oral gluten challenge, which had a fixed sequence. Meanwhile, biopsy cohorts received a gastroscopy with duodenal biopsies and quantitative histology within 2 weeks without oral gluten challenge. Of the participants who completed the post-treatment oral gluten challenge per protocol, interferon γ release assay to Nexvax2 peptides was negative in two (22%) of nine placebo-treated participants in the three-dose study.
    Compared with two (33%) of six who received Nexvax2 60 μg, five (63%) of eight who received Nexvax2 90 μg, and six (100%) of six who received Nexvax2 150 μg (p=0·007); in the 16-dose study, none (0%) of five placebo-treated participants had a negative assay versus six (75%) of eight who received Nexvax2 150 μg (p=0·021).
    The MTD of Nexvax2 was 150 μg for twice weekly intradermal administration over 8 weeks, which modified immune responsiveness to Nexvax2 peptides with no adverse impact on duodenal histology.
    Patients who received the intradermal administration of the vaccine reported gastrointestinal symptoms were not subtantially different to those seen with oral gluten challenge.
    While the commercial release of a viable vaccine is likely still some time away, early-phase trials have shown promise. Based on these results, ImmusanT will continue clinical development of this potentially therapeutic vaccine for celiac disease.
    Both trials were completed and closed before data analysis. Trials were registered with the Australian New Zealand Clinical Trials Registry, numbers ACTRN12612000355875 and ACTRN12613001331729.
    Source:
    The Lancet Affiliations:
    The researchers are variously affiliated with the Division of Gastroenterology and Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA, USA, the Broad Institute of Harvard and Massachusetts Institute of Technology, Cambridge, MA, USA; the Department of Gastroenterology, Auckland City Hospital, Auckland, New Zealand; the School of Medicine, University of Queensland, Brisbane, QLD, Australia; the Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, SA, Australia; the Linear Clinical Research, Nedlands, WA, Australia; the Department of Gastroenterology, Alfred Hospital, Prahran, VIC, Australia; the Clinical Research Institute of Michigan, Chesterfield, MI, USA; the University of North Carolina School of Medicine, Chapel Hill, NC, USA; Wake Gastroenterology and Wake Research Associates, Raleigh, NC, USA; Atlantic Digestive Specialists, Portsmouth, NH, USA; Ridgeview Medical Center, Waconia, MN, USA; Oklahoma Foundation for Digestive Research, Oklahoma City, OK, USA; ClinSearch, Chattanooga, TN, USA; the Immunology Division, Walter and Eliza Hall Institute of Medical Research, Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia; the Murdoch Children's Research Institute and Department of Gastroenterology, Royal Melbourne Hospital, Parkville, VIC, Australia; the Immunology Division, Walter and Eliza Hall Institute of Medical Research, Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Alfred Rusescu Institute for Mother and Child Care and Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, La Jolla, CA, USA; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Centre for Immune Regulation, KG Jebsen celiac Disease Research Centre, and Department of Immunology, University of Oslo, Oslo, Norway; the Oslo University Hospital-Rikshospitalet, Oslo, Norway; Department of Pediatrics, Department of Medicine, University of Chicago, Chicago, IL, USA; and ImmusanT in Cambridge, MA, USA.

    Jefferson Adams
    Celiac.com 06/26/2017 - Designed to reduce or eliminate symptoms of gluten contamination in gluten-sensitive individuals, the product known as AN-PEP, marketed in the U.S. as Tolerase G, is a prolyl endoprotease enzyme, derived from Aspergillus niger, that has shown promise in breaking down gluten proteins.
    The latest news comes in the form of a small study that shows the enzyme to be effective in the stomach itself, where harshly acidic conditions render many enzymes ineffective.
    Speaking to an audience at Digestive Disease Week (DDW) 2017, lead investigator Julia König, PhD, of Sweden's Örebro University, said that the enzyme was special, because…[t]here are a lot of enzymes on the market, but this functions in the stomach where the pH is acidic. Often enzymes don't work in this environment."
    König was also quick to caution that "you cannot use this enzyme to treat or prevent celiac disease." The enzyme is not intended to replace a gluten-free diet for celiac patients.
    The enzyme is designed to provide some protection against cross-contamination for people with gluten-sensitivity by breaking down modest amounts of gluten to reduce or prevent adverse immune reaction.
    A previous study showed that AN-PEP breaks down gluten after an intra-gastrically infused liquid meal in healthy volunteers (Aliment Pharmacol Ther. 2015;42:273-285).
    In the latest randomized placebo-controlled crossover study, Dr König and her colleagues assessed the ability of AN-PEP to degrade gluten after a normal meal in people with gluten sensitivity.
    The research team looked at 18 people with self-reported gluten sensitivity, and with no confirmation of celiac disease. On three separate visits, investigators collected gastric and duodenal aspirates with a multilumen nasoduodenal-feeding catheter.
    Participants then consumed a porridge containing gluten, approximately 0.5 g, in the form of two crumbled wheat cookies. They also consumed a tablet containing AN-PEP at either 160,000 PPi or 80,000 PPi), or placebo. Investigators collected stomach and duodenal aspirates over the following 3 hours.
    In both the high- and low-dose AN-PEP groups, gluten concentrations in the stomach and in the duodenum were substantially lower than in the placebo group.
    This study shows that AN-PEP does break down gluten in the stomach, where many enzymes fail. If successfully tested and commercially released, AN-PEP could help people with gluten sensitivity, including those with celiac disease, to reduce or eliminate symptoms associated with casual gluten contamination.
     Source:
    Medscape

    Jefferson Adams
    Celiac.com 08/12/2017 - The latest research report from HTF Market Intelligence Consulting is titled "Global Celiac Disease Drugs Market 2017-2021." The report offers detailed information and analysis of the competitive market landscape, forecast and strategies.
    The report covers geographic analysis that includes regions like Americas, APAC, EMEA, along with important players, including F. Hoffmann-La Roche, Johnson & Johnson, Merck, and Pfizer. It provides information, market insights, future trends and growth prospects for forecast period of 2017-2021.
    The report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources, and research analysts project the global market for celiac disease drugs to grow at a CAGR of 24.22% during the period through 2021.
    The primary treatment for celiac disease is still a completely gluten-free diet. There are a small number of anti-inflammatory and immunosuppressant drugs and nutritional supplements that are used as off-label, secondary treatments in celiac disease, but as yet, no drugs approved for primary treatment of celiac disease.
    Development of such treatments for celiac disease offers huge potential for profit to any company who can get a drug approved for the commercial market. The growth projections attempt to reflect the data behind a fast growing global market.
    Request a sample report at: htfmarketreport.com
     

  • Recent Articles

    Jefferson Adams
    Celiac.com 06/21/2018 - Would you buy a house advertised as ‘gluten-free’? Yes, there really is such a house for sale. 
    It seems a Phoenix realtor Mike D’Elena is hoping that his trendy claim will catch the eye of a buyer hungry to avoid gluten, or, at least one with a sense of humor. D’Elena said he crafted the ads as a way to “be funny and to draw attention.” The idea, D’Elena said, is to “make it memorable.” 
    Though D’Elena’s marketing seeks to capitalizes on the gluten-free trend, he knows Celiac disease is a serious health issue for some people. “[W]e’re not here to offend anybody….this is just something we're just trying to do to draw attention and do what's best for our clients," he said. 
    Still, the signs seem to be working. D'elena had fielded six offers within a few days of listing the west Phoenix home.
    "Buying can sometimes be the most stressful thing you do in your entire life so why not have some fun with it," he said. 
    What do you think? Clever? Funny?
    Read more at Arizonafamily.com.

    Advertising Banner-Ads
    Bakery On Main started in the small bakery of a natural foods market on Main Street in Glastonbury, Connecticut. Founder Michael Smulders listened when his customers with Celiac Disease would mention the lack of good tasting, gluten-free options available to them. Upon learning this, he believed that nobody should have to suffer due to any kind of food allergy or dietary need. From then on, his mission became creating delicious and fearlessly unique gluten-free products that were clean and great tasting, while still being safe for his Celiac customers!
    Premium ingredients, bakeshop delicious recipes, and happy customers were our inspiration from the beginning— and are still the cornerstones of Bakery On Main today. We are a fiercely ethical company that believes in integrity and feels that happiness and wholesome, great tasting food should be harmonious. We strive for that in everything we bake in our dedicated gluten-free facility that is GFCO Certified and SQF Level 3 Certified. We use only natural, NON-GMO Project Verified ingredients and all of our products are certified Kosher Parve, dairy and casein free, and we have recently introduced certified Organic items as well! 
    Our passion is to bake the very best products while bringing happiness to our customers, each other, and all those we meet!
    We are available during normal business hours at: 1-888-533-8118 EST.
    To learn more about us at: visit our site.

    Jefferson Adams
    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

    Jefferson Adams
    Celiac.com 06/19/2018 - Could baking soda help reduce the inflammation and damage caused by autoimmune diseases like rheumatoid arthritis, and celiac disease? Scientists at the Medical College of Georgia at Augusta University say that a daily dose of baking soda may in fact help reduce inflammation and damage caused by autoimmune diseases like rheumatoid arthritis, and celiac disease.
    Those scientists recently gathered some of the first evidence to show that cheap, over-the-counter antacids can prompt the spleen to promote an anti-inflammatory environment that could be helpful in combating inflammatory disease.
    A type of cell called mesothelial cells line our body cavities, like the digestive tract. They have little fingers, called microvilli, that sense the environment, and warn the organs they cover that there is an invader and an immune response is needed.
    The team’s data shows that when rats or healthy people drink a solution of baking soda, the stomach makes more acid, which causes mesothelial cells on the outside of the spleen to tell the spleen to go easy on the immune response.  "It's most likely a hamburger not a bacterial infection," is basically the message, says Dr. Paul O'Connor, renal physiologist in the MCG Department of Physiology at Augusta University and the study's corresponding author.
    That message, which is transmitted with help from a chemical messenger called acetylcholine, seems to encourage the gut to shift against inflammation, say the scientists.
    In patients who drank water with baking soda for two weeks, immune cells called macrophages, shifted from primarily those that promote inflammation, called M1, to those that reduce it, called M2. "The shift from inflammatory to an anti-inflammatory profile is happening everywhere," O'Connor says. "We saw it in the kidneys, we saw it in the spleen, now we see it in the peripheral blood."
    O'Connor hopes drinking baking soda can one day produce similar results for people with autoimmune disease. "You are not really turning anything off or on, you are just pushing it toward one side by giving an anti-inflammatory stimulus," he says, in this case, away from harmful inflammation. "It's potentially a really safe way to treat inflammatory disease."
    The research was funded by the National Institutes of Health.
    Read more at: Sciencedaily.com

    Jefferson Adams
    Celiac.com 06/18/2018 - Celiac disease has been mainly associated with Caucasian populations in Northern Europe, and their descendants in other countries, but new scientific evidence is beginning to challenge that view. Still, the exact global prevalence of celiac disease remains unknown.  To get better data on that issue, a team of researchers recently conducted a comprehensive review and meta-analysis to get a reasonably accurate estimate the global prevalence of celiac disease. 
    The research team included P Singh, A Arora, TA Strand, DA Leffler, C Catassi, PH Green, CP Kelly, V Ahuja, and GK Makharia. They are variously affiliated with the Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Lady Hardinge Medical College, New Delhi, India; Innlandet Hospital Trust, Lillehammer, Norway; Centre for International Health, University of Bergen, Bergen, Norway; Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Gastroenterology Research and Development, Takeda Pharmaceuticals Inc, Cambridge, MA; Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy; Department of Medicine, Columbia University Medical Center, New York, New York; USA Celiac Disease Center, Columbia University Medical Center, New York, New York; and the Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.
    For their review, the team searched Medline, PubMed, and EMBASE for the keywords ‘celiac disease,’ ‘celiac,’ ‘tissue transglutaminase antibody,’ ‘anti-endomysium antibody,’ ‘endomysial antibody,’ and ‘prevalence’ for studies published from January 1991 through March 2016. 
    The team cross-referenced each article with the words ‘Asia,’ ‘Europe,’ ‘Africa,’ ‘South America,’ ‘North America,’ and ‘Australia.’ They defined celiac diagnosis based on European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines. The team used 96 articles of 3,843 articles in their final analysis.
    Overall global prevalence of celiac disease was 1.4% in 275,818 individuals, based on positive blood tests for anti-tissue transglutaminase and/or anti-endomysial antibodies. The pooled global prevalence of biopsy-confirmed celiac disease was 0.7% in 138,792 individuals. That means that numerous people with celiac disease potentially remain undiagnosed.
    Rates of celiac disease were 0.4% in South America, 0.5% in Africa and North America, 0.6% in Asia, and 0.8% in Europe and Oceania; the prevalence was 0.6% in female vs 0.4% males. Celiac disease was significantly more common in children than adults.
    This systematic review and meta-analysis showed celiac disease to be reported worldwide. Blood test data shows celiac disease rate of 1.4%, while biopsy data shows 0.7%. The prevalence of celiac disease varies with sex, age, and location. 
    This review demonstrates a need for more comprehensive population-based studies of celiac disease in numerous countries.  The 1.4% rate indicates that there are 91.2 million people worldwide with celiac disease, and 3.9 million are in the U.S.A.
    Source:
    Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037.