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    Jefferson Adams is a freelance writer living in San Francisco. He has covered Health News for Examiner.com, and provided health and medical content for Sharecare.com. His work has appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate, among others.

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    Jefferson Adams
    Celiac.com 03/27/2017 - A number of researchers are looking to provide alternative or adjunct treatments to the gluten-free diet in celiac disease. Meanwhile, a number of companies are currently developing a wide variety of such options, ranging from various kinds of enzyme therapies, to treatments that eliminate celiac disease reactions, even to vaccines to inoculate celiac sufferers against their condition, perhaps allowing for full recovery and a return to non-gluten-free eating habits, as desired. At least, that's one dream.
    More likely will be the development of enzymes or other treatments that offer celiacs varying degrees of protection from gluten ingestion. Most likely, such treatments would be designed to augment an existing gluten-free diet, and to provide protection against moderate gluten-contamination when eating out.
    One particular enzyme that shows strong potential in breaking down toxic peptides in A-gliadin, the main culprit in celiac reactions, is caricain. A recent paper discusses the scientific principles behind the use of caricain for enzyme therapy. The paper is based on a recent study, in which a team of researchers set out to review the structures of the toxic peptides in A-gliadin for key sequences of amino acids or motifs related to toxicity, especially with respect to digestive difficulties, or immunogenicity.
    The research team included Hugh J. Cornell and Teodor Stelmasiak. They are affiliated with the RMIT University, School of Applied Sciences, Melbourne, Australia, and with Glutagen Pty Ltd, Maribyrnong, Victoria, Australia.
    For their study, they first evaluated structures of synthetic A-gliadin peptides shown to be toxic in the fetal chick assay, both before and after digestion with duodenal mucosa from patients in long remission.
    They also measured synthetic peptides corresponding to the undigested residues, and compared the key amino acid sequences, to see if they might be related to direct toxicity and immunogenicity of the peptides.
    They found that the smallest toxic peptides from celiac mucosal digestion were octa-peptides, which they found in greater amounts than similar products from normal digestion.
    One of those peptides corresponded to residues 12-19 of A-gliadin and contained the key motifs PSQQ and QQQP of De Ritis et al., while the other corresponded to residues 72-79, and contained the key motif PYPQ (extending to PYPQPQ).
    These key motifs have been noted by other workers, especially those investigating immunological activity over the past two decades. Their in undigested residues from celiac mucosal digestion
    These motifs, along with the greater prevalence of these residues, as compared with residues from normal digestion, supports the basic notions underpinning enzyme therapy for celiac disease.
    These study also supports the basic scientific merits of research and development of the enzyme caricain to break down gliadin peptides with two different types of toxicity, and thus to potentially benefit people with celiac disease.
    Source:
    International Journal of Celiac Disease. Vol. 4, No. 4, 2016, pp 113-120. doi: 10.12691/ijcd-4-4-2 Previous study: NCBI

    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 08/28/2017 - After 14-day gluten challenge, an HLA-DQ-gluten tetramer blood test provides better detection of celiac disease than biopsy. Can that lead to new disease detection methods in patients who are already on a gluten-free diet?
    Doctors attempting to diagnose celiac disease are often confronted by patients who have already given up gluten. For such patients, diagnostic guidelines currently call for a gluten challenge of at least 14 days, followed by duodenal biopsy. There isn't much good data on how many false-positive results are generated by this method. To get a better picture, a team of researchers recently studied responses to 14-day gluten challenge in subjects with treated celiac disease.
    The research team included Vikas K Sarna, Gry I Skodje, Henrik M Reims, Louise F Risnes, Shiva Dahal-Koirala, Ludvig M Sollid, and Knut E A Lundin. They are variously affiliated with the Department of Immunology and Transfusion Medicine, Oslo University Hospital, Norway; K. G. Jebsen Coeliac Disease Research Centre, University of Oslo, Norway; Department of Clinical Service, Oslo University Hospital, Norway; Department of Pathology, Oslo University Hospital, Norway; Centre for Immune Regulation, University of Oslo and Oslo University Hospital, Norway; and the Department of Gastroenterology, Oslo University Hospital, Norway.
    The research team took a group of 20 patients with biopsy-verified celiac disease, all in confirmed mucosal remission, and presented them with a dietary gluten challenge of 5.7 grams per oral gluten per day for 14 days, then conducted duodenal biopsies. They analyzed blood by multiplex assay for cytokine detection, and by flow cytometry using HLA-DQ:gluten tetramers.
    Nineteen of the twenty participants completed the challenge. Biopsy results showed villous blunting in 5 of those 19 patients. Villous height to crypt depth ratio reduced with at least 0.4 concomitantly with an increase in intraepithelial lymphocyte count of at least 50% in 9 of the 19 patients. Interleukin-8 plasma concentration increased by more than 100% after 4 hours in 7 of 19 subjects. Frequency of blood CD4+effector-memory gut-homing HLA-DQ:gluten tetramer-binding T cells increased by more than 100% on day 6 in 12 of 15 evaluated participants.
    For most celiac patients, a 14-day gluten challenge did not result in sufficient mucosal architectural changes for clear diagnosis (sensitivity ≈25%–50%).
    The team found that an increase in CD4+ effector-memory gut-homing HLA-DQ:gluten tetramer-binding T cells in blood 6 days after gluten challenge is a more sensitive and less invasive biomarker for celiac disease.
    The team is calling for further study. Being able to diagnose celiac disease without biopsy could really help to improve the entire diagnostic process, and could easily lead to an increase in diagnosis.
    Source:
    Gut

    Jefferson Adams
    Celiac.com 09/19/2017 - Hookworms. Intestinal parasites. They sound gross. The thought of having one's gut infected with a parasitic worm generally makes people's skin crawl. Indeed, intestinal worms, like hookworm, have a bad reputation among health experts, and have been the subject of fierce public health campaigns seeking their eradication. However, researchers have also documented the gut healing abilities of parasites like hookworm.
    In fact, part of how hookworms seem to work in nature is to promote an optimal gut environment in which they can thrive. In nature, the guts of people infected with hookworm are generally healthy. Could hookworms and other intestinal parasites prove key to treating and possibly eliminating diseases like celiac, and asthma?
    A number of clinicians and researchers feel that if they can just get the right strain of hookworm, at the right levels, they can basically eradicate celiac disease, and possibly asthma and other inflammatory diseases.
    When hookworms are introduced into the gut of people with celiac disease in the right amount, and kept at therapeutic levels, patients see their celiac symptoms disappear and their guts return to a healthy, normal condition. In fact, hookworms do not reproduce once inside the human gut, so if doctors put , say, 10 hookworms into a gut to treat celiac disease, there will be 10 there later, not more. In nature, the way humans build up dangerous levels of hookworm is via unsanitary environmental conditions and repeated exposure to more hookworms. Done clinically, the hookworm would present little or no danger to the human who was hosting it.
    While still very much in the experimental phase, researchers hope to investigate a number of strains to determine the best therapeutic levels for such disease treatments. For that, they will need FDA approval.
    Remember, the fecal transplant was first described in the 1950s, but took decades to catch on as a conventional treatment for gut disorders, such as c-dif bacteria, partly because it was seen as crude and somehow objectionable. But it proved to work. Really well. So much so that it's now a fairly conventional treatment.
    Could the hookworm follow a similar path from crude and weird to cool and effective? Could hookworms be used to cure celiac disease? Only close study will tell us for sure, and that's why the move to get FDA approval is an important one.
    For that, special strains of hookworm must be approved. "One of the big roadblocks is having the parasites that the FDA will allow you to infect people with," says John Hawdon, vice president of the American Society of Parasitologists and a researcher at the George Washington University.
    He and his colleagues are applying for permission to grow hookworm larvae to standards fit for testing in humans, which is not currently permitted in the United States. Hawdon says he anticipates a lengthy application process.
    Stay tuned for news on efforts to develop hookworm as a potential cure to celiac disease, asthma, and more.
    Sources:
    popsci.com iflscience.com

    Jean Duane
    Celiac.com 09/20/2017 - A half-time report on what we've learned about each other so far in the Relational Aspects of Food Sensitivities research.
    The study is geared toward gaining perspective on the perceived impact one adult's food restrictions cause in a household when cohabitating with other adults. It may ultimately yield strategies to address the social and emotional impact of living with food sensitivities. It aims to provide coping strategies, solidarity and empowerment to our community.
    If you haven't had a chance to take the survey, unfortunately it's not too late. If you have, thank you! More about the survey will appear in the next issue and the four lucky $25 Amazon gift card winners will be announced next month as well.
    Here's what we've learned so far:
    Ninety-six percent (96%) of those who took the survey have a diagnosis that leads them to be on a gluten-free diet. Fifty-one percent (51%) have been diagnosed for 8+ years; 28% have been diagnosed between 4-7 years, 13% between 1-3 years, 5% between 7 months and 1 year, and 3% between 0-6 months. Most began eating a gluten-free diet immediately after being diagnosed. Fifty-two percent feel that the way they were diagnosed affects how seriously the other adult(s) living in the household take their dietary requirements and 23% report that the way they were diagnosed doesn't affect the behavior of the other residential adults at all.
    When it comes to how diagnosed, 73% were diagnosed by an MD; 12% by themselves; 5% by a Practitioner, 5% by "Other;" 3% by a Naturopath and 2% by a Nutritionist. Forty-six percent (46%) report that they check in with a medical or health professional to monitor their health/diet once a year, and 21% get checkups several times a year. Most of us get our medical, health and dietary information we implement into our lifestyle from online sources (39%), books/magazines (21%) and from the MD (17%). The other 23% who took the survey get information from TV/Media, friends, and other sources. Because of the high-quality content available on websites such as Celiac.com, 87% report they are definitely not confused as to which foods are considered to be gluten-free. Sixty-percent (62%) of the respondents' report that other adults in the household are definitely not confused as to which foods are considered to be gluten-free.
    Ninety-two percent (92%) of us are not confused about what constitutes a "healthy diet." Thirty-eight percent (38%) feel they eat a healthy diet all the time, 48% eat a healthy diet most of the time, 11% eat a healthy diet sometimes, and 3% never eat a healthy diet. Our diet includes gluten-free grains 83% of the time, while 17% of us are grain-free.
    Adult cohabitants 'almost always' follow the same dietary requirements as we do in 56% of the households, 'sometimes' in 32% and 'rarely' in 12% of the households. Fifty-seven percent (57%) of us report that we eat different foods than the other adults living in the household 'sometimes,' while 22% of us do that 'rarely' and 21% almost always eat different foods. Adults with food sensitivities in 19% of the households enjoy meals prepared by another adult most of the time, 'sometimes' in 46% and never in 36% of the homes. Sixty-seven percent (67%) of those who eat meals prepared by another adult in their household trust that the meals are safe for them to eat.
    Fifty-one percent (51%) of those who took the survey report that someone else in the household prepares meals for them one to five times a week while 45% report they make all of their meals themselves. Most of us (95%) never cheat on the gluten-free diet.
    Demographics of the Respondents
    Eighty-five percent (85%) of the respondents are female and 15% are male. Ninety-two (92%) are white, most (65%) live with one other adult. Thirty-four point sixty two percent (34%) have a Bachelor's degree and 23% have a Masters degree. Household income was between $75-149K for 33% of the respondents.
    In-Depth Interview – Phase II
    For those of you who answered, "yes" to the Phase II interview (the longer-term portion of the research) and haven't heard from me yet, please be patient. I'm working with some time constraints now that fall quarter classes have begun and will be contacting some of you in the coming months to schedule a time to talk.

    Jefferson Adams
    Celiac.com 09/25/2017 - There are currently several efforts underway to develop successful commercial enzyme treatments for celiac disease. Efforts include looking at the digestive enzymes in plants, such as the papaya and star fruits, including such predatory plants, such as the pitcher plant.
    One focus has been on developing enzymes that can break down gluten before it can trigger an immune reaction. This could prove helpful to many people with celiac disease.
    One such enzyme under development is Latiglutenase, formerly known as ALV003. Latiglutenase is a new name for an enzyme therapy designed to be taken with meals.
    The idea is that a person with celiac disease would take an enzyme tablet with a meal. If the meal had mild gluten contamination, the enzyme’s two recombinant proteins would break gluten into fragments that are not toxic to the immune system, thereby preventing exposure, and symptoms.
    But the stomach is a notoriously difficult environment to work in, so what seems like a simple idea quite a challenge from a science and biology perspective.
    Seeking to explore the ability of Latiglutinase to improve symptoms, a team of researchers recently set out to test latiglutenase on celiac patients who are seropositive despite following a gluten-free diet.
    The research team included Jack A. Syage, Joseph A. Murray, Peter H. R. Green and Chaitan Khosla. They are variously affiliated with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester USA, the Celiac Disease Center at Columbia University, New York, USA, the Departments of Chemical Engineering and Chemistry, Stanford University, USA, and with ImmunogenX, Newport Beach, USA.
    "Though the ALV003-1221 trial was inconclusive regarding histologic improvement from latiglutenase, the evidence for symptom benefit, which is more quickly achieved, is quite convincing and clinically relevant," Joseph Murray, MD, of the Mayo Clinic in Rochester, Minn., said in a press release.
    In these trials, patients with celiac disease who were seropositive despite following a gluten-free diet saw major improvement in symptoms when taking latiglutenase with meals, according to a post hoc analysis of the CeliAction study.
    The team was really hoping to see histological improvement, but they feel satisfied that this trial shows, says Dr. Murray, that a "therapy to help patients struggling with symptoms due to celiac disease is now within reach."
    Stay tuned for more on efforts to develop effective enzyme treatments for celiac disease.
    Read more: Dig Dis Sci. 2017 Doi:10.1007/s10620-017-4687-7.

    Jefferson Adams
    Celiac.com 10/02/2017 - For anyone following the efforts by ImmusanT to develop a vaccine for celiac disease, the company's recent presentations at the 2017 International Celiac Disease Symposium (ICDS) in New Delhi, India, were welcome news.
    Nexvax2® is a therapeutic vaccine intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease.
    The company announced at ICDS 2017 that it has presented data showing the immunologic basis for the early clinical effects of gluten in celiac disease.
    Presented in two poster presentations and an oral presentation, the company says its data show that "early cytokine changes in blood following gluten ingestion could provide the basis for a new diagnostic for celiac disease in patients on a gluten free diet with an uncertain diagnosis," said Robert Anderson, MBChB, Ph.D., Chief Scientific Officer of ImmusanT.
    The company says its results are "significant" because celiac disease sufferers often adopt a gluten-free diet prior to being diagnosed by a doctor. This can cause problems and lead to unreliable or misleading results with current diagnostic tests.
    ImmusanT says that their data demonstrate that early changes in circulating cytokines after a single gluten exposure may offer a clinical way to assess celiac disease activity.
    The company says that the data, along with the potential to differentiate between celiac disease and non-celiac gluten sensitivity (NCGS) by assessing IL-2 levels, support the science behind targeted immunotherapies such as Nexvax2®.
    Read more at BusinessWire.com

    Jefferson Adams
    Celiac.com 12/22/2017 - Venture capital firms Arch Venture, and Vatera are betting big on biotech startup ImmusanT, the makers of potential celiac disease vaccine Nexvax2.
    Arch and Vatera have funded a $40 million B round that will support ImmusanT's development of their celiac treatment through Phase II testing. Full data are expected in mid-2019.
    As part of it's efforts, Arch Venture partner and former head of research at Celgene, Tom Daniel, will join the board at ImmusanT. Additionally, renowned immunologist and Arch managing director Steven Gillis will also join the board at ImmusanT.
    Nexvax2 is the first prong in ImmusanT's efforts to develop a treatment that creates immune system tolerance to thwart autoimmune diseases. If they are successful in tackling celiac disease, the company is looking to expand the technology to include treatments for type 1 diabetes and other ailments.
    Celiac disease is a great place to start, says ImmusanT CEO Leslie Williams, because scientists already know the antigen that triggers the disease.
    Williams says that her company has scoured 17,000 peptides to "create a hierarchy of the key components that trigger the T cell response" in celiac disease. Nexvax2 is designed to work by slowly coaxing the immune system to ignore the trigger. Patients exposed to Nexvax2 react as if they have eaten gluten, says Williams. The goal is to harness that immune reactions and to modulate it.
    Williams is looking to double the size of the company's tiny 7-person staff as the ImmusanT journeys through a mid-stage trial.
    She will then look to an expanded set of programs as well as the data to determine the best direction for the company. Williams says that all options are currently open, including another funding round, an IPO or even a strategic deal.
    Read more at: endpts.com

    Jefferson Adams
    Celiac.com 01/04/2018 - Nexvax2 is a peptide-based, epitope-specific immunotherapy intended to reduce reactions to natural gluten exposure, and ultimately restore tolerance to gluten in patients with celiac disease.
    Celiac disease patients who received fixed intradermal doses of Nexvax2 lost their sensitivity to the HLA-DQ2·5-restricted gluten epitopes in Nexvax2, but their tolerance was limited to 150 μg, due to gastrointestinal symptoms and cytokine release, mimicking gluten exposure, that accompany the first dose.
    A team of researchers recently set out to test whether small doses in steps might reduce the first dose effect of Nexvax2 in celiac disease patients.
    The research team included James M. Daveson, Hooi C. E, Jane M. Andrews, Timothy King, Kaela E. Goldstein, John L. Dzuris, James A. MacDougall; Leslie J. Williams, Anita Treohan, Michael P. Cooreman, and Robert P. Anderson.
    They are variously associated with the Faculty of Medicine, University of Queensland, QLD, Australia b Department of Gastroenterology, Sir Charles Gairdner Hospital, WA, Australia; Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, SA, Australia; Department of Gastroenterology, Auckland City Hospital, Auckland, New Zealand; PROMETRIKA, LLC, Cambridge, MA, USA; and ImmusanT Inc., Cambridge, MA, USA.
    The team conducted a randomized, double-blind, placebo-controlled trial at four community sites in Australia (3) and New Zealand (1) in HLA-DQ2·5 genotype positive adults with celiac disease who were on a gluten-free diet.
    By using doses escalated from 3 μg up to 300 μg in HLA-DQ2·5 homozygotes or to 900 μg in HLADQ2.5 non-homozygotes the team was able to eliminate the adverse events and cytokine release that had limited the previous maximum dose to 150 μg.
    Administration of Nexvax2 at dose levels from 150 μg to 900 μg preceded by dose escalation was not associated with elevations in plasma cytokines at 4 h.
    Otherwise, the most common treatment-related side effects in the Nexvax2 participants were headache (52%), diarrhea (48%), nausea (37%), abdominal pain (26%), and abdominal discomfort (19%).
    This study shows that antigenic peptides recognized by CD4-positive T cells in an autoimmune disease can be safely administered to patients at high maintenance dose levels without immune activation when preceded by gradual dose escalation.
    These findings help further these efforts to develop a successful immunotherapy drug to treat celiac disease.
    Read more at Ebiomedicine.com
    This completed trial is registered with ClinicalTrials. gov, number NCT02528799.
     

  • Recent Articles

    Jefferson Adams
    Celiac.com 07/17/2018 - What can fat soluble vitamin levels in newly diagnosed children tell us about celiac disease? A team of researchers recently assessed fat soluble vitamin levels in children diagnosed with newly celiac disease to determine whether vitamin levels needed to be assessed routinely in these patients during diagnosis.
    The researchers evaluated the symptoms of celiac patients in a newly diagnosed pediatric group and evaluated their fat soluble vitamin levels and intestinal biopsies, and then compared their vitamin levels with those of a healthy control group.
    The research team included Yavuz Tokgöz, Semiha Terlemez and Aslıhan Karul. They are variously affiliated with the Department of Pediatric Gastroenterology, Hepatology and Nutrition, the Department of Pediatrics, and the Department of Biochemistry at Adnan Menderes University Medical Faculty in Aydın, Turkey.
    The team evaluated 27 female, 25 male celiac patients, and an evenly divided group of 50 healthy control subjects. Patients averaged 9 years, and weighed 16.2 kg. The most common symptom in celiac patients was growth retardation, which was seen in 61.5%, with  abdominal pain next at 51.9%, and diarrhea, seen in 11.5%. Histological examination showed nearly half of the patients at grade Marsh 3B. 
    Vitamin A and vitamin D levels for celiac patients were significantly lower than the control group. Vitamin A and vitamin D deficiencies were significantly more common compared to healthy subjects. Nearly all of the celiac patients showed vitamin D insufficiency, while nearly 62% showed vitamin D deficiency. Nearly 33% of celiac patients showed vitamin A deficiency. 
    The team saw no deficiencies in vitamin E or vitamin K1 among celiac patients. In the healthy control group, vitamin D deficiency was seen in 2 (4%) patients, vitamin D insufficiency was determined in 9 (18%) patients. The team found normal levels of all other vitamins in the healthy group.
    Children with newly diagnosed celiac disease showed significantly reduced levels of vitamin D and A. The team recommends screening of vitamin A and D levels during diagnosis of these patients.
    Source:
    BMC Pediatrics

    Jefferson Adams
    Celiac.com 07/16/2018 - Did weak public oversight leave Arizonans ripe for Theranos’ faulty blood tests scam? Scandal-plagued blood-testing company Theranos deceived Arizona officials and patients by selling unproven, unreliable products that produced faulty medical results, according to a new book by Wall Street Journal reporter, whose in-depth, comprehensive investigation of the company uncovered deceit, abuse, and potential fraud.
    Moreover, Arizona government officials facilitated the deception by providing weak regulatory oversight that essentially left patients as guinea pigs, said the book’s author, investigative reporter John Carreyrou. 
    In the newly released "Bad Blood: Secrets and Lies in a Silicon Valley Startup," Carreyrou documents how Theranos and its upstart founder, Elizabeth Holmes, used overblown marketing claims and questionable sales tactics to push faulty products that resulted in consistently faulty blood tests results. Flawed results included tests for celiac disease and numerous other serious, and potentially life-threatening, conditions.
    According to Carreyrou, Theranos’ lies and deceit made Arizonans into guinea pigs in what amounted to a "big, unauthorized medical experiment.” Even though founder Elizabeth Holmes and Theranos duped numerous people, including seemingly savvy investors, Carreyrou points out that there were public facts available to elected officials back then, like a complete lack of clinical data on the company's testing and no approvals from the Food and Drug Administration for any of its tests.
    SEC recently charged the now disgraced Holmes with what it called a 'years-long fraud.’ The company’s value has plummeted, and it is now nearly worthless, and facing dozens, and possibly hundreds of lawsuits from angry investors. Meantime, Theranos will pay Arizona consumers $4.65 million under a consumer-fraud settlement Arizona Attorney General Mark Brnovich negotiated with the embattled blood-testing company.
    Both investors and Arizona officials, “could have picked up on those things or asked more questions or kicked the tires more," Carreyrou said. Unlike other states, such as New York, Arizona lacks robust laboratory oversight that would likely have prevented Theranos from operating in those places, he added.
    Stay tuned for more new on how the Theranos fraud story plays out.
    Read more at azcentral.com.

    Jefferson Adams
    Celiac.com 07/14/2018 - If you’re looking for a simple, nutritious and exciting alternative to standard spaghetti and tomato sauce, look no further than this delicious version that blends ripe plum tomatoes, garlic, olive oil, basil, and firm sliced ricotta to deliver a tasty, memorable dish.
    Ingredients:
    12 ounces gluten-free spaghetti 5 or 6 ripe plum tomatoes ¼ cup extra virgin olive oil 2 cloves garlic, crushed ¾ teaspoons crushed red pepper ¼ cup chopped fresh basil 2 tablespoons chopped fresh parsley Kosher salt and black pepper ⅓ cup pecorino Romano cheese, grated ½ cup firm ricotta, shaved with peeler Directions:
    Finely chop all but one of the tomatoes; transfer to large bowl with olive oil and ¼ teaspoon salt.
    Cook spaghetti until al dente or desired firmness, and drain, reserving ¼ cup cooking water. 
    Meanwhile, chop remaining tomato, and place in food processor along with garlic, red pepper, and ½ teaspoon salt; puree until smooth. 
    Gently stir mixture into the bowl of chopped tomatoes.
    Add cooked spaghetti, basil and parsley to a large bowl.
    Toss in tomato mixture, adding some reserved pasta water, if needed. 
    Spoon pasta into bowls and top with Romano cheese, as desired.

    Jean Duane
    Celiac.com 07/13/2018 - I went to a friend’s home for dinner.  A few days before, she called and asked me what I could eat.  I asked her what she was planning to make, and she said she was grilling meats with side dishes.  I said, “Great.  Please just grill a piece of chicken for me with salt and pepper, and I’ll be happy to bring a side.” She said, “No need to bring a side.  I’ve got this.” When I arrived, she greeted me and said, “I spent all day cooking tonight’s dinner so you can eat it. Hey would you just check this salad dressing to see if it is OK for you?” I looked at the ingredients and it contained gluten and dairy, both of which I cannot eat.  Then I glanced around the kitchen and saw evidence of wheat cross-contamination, including buns being toasted on the grill, and gluten-containing barbeque sauce spilling on the grill where my “clean” chicken was cooking. She had other guests to tend to, and I couldn’t offer instruction or read the ingredients of everything she used in the meal. 
    At social gatherings, I’ve been challenged too by those who ask if I am really “allergic,” or just eating gluten free as a “fad.” I’ve been told many times by hosts and hostesses that, “a little won’t hurt you,” or “everything in moderation,” or “if it is made with loving hands, it is good for you to eat.”  Of course, all of this is bunk for those with food allergies or celiac disease.  A little bit may kill us, and whether made with loving hands or not, it will certainly make us sick. 
    Those of us with food allergies and/or celiac disease walk a tightrope with friends and relatives. The old rules of etiquette just don’t work anymore.  We don’t want to insult anybody, we don’t want to be isolated, and we also don’t want to risk our health by eating foods that may contain ingredients we cannot tolerate.  So what do we do? 
    Etiquette books advise us to eat what is put in front of us when we are guests in someone’s home. They caution us at all costs not to insult our hostess. Rather, we are instructed to compliment the hostess on her good cooking, flavor combinations, and food choices.  But when foods are prepared in a cross-contaminated environment with ingredients we are allergic to, we cannot follow the old social constructs that do not serve us.  We need to work together to rewrite the rules, so that we can be included in social gatherings without fear of cross-contamination, and without offending anyone.
    Let’s figure out how to surmount these social situations together.  
    Each edition of this column will present a scenario, and together, we’ll determine appropriate, polite, and most importantly, safe ways to navigate this tricky gluten-free/food allergies lifestyle in a graceful way.  If someone disagrees with our new behavior patterns, we can refer them to this column and say, “Here are the new rules for those of us with food allergies or celiac disease.”  When we are guests in someone’s home, we can give them links to this column so they understand the plight we are faced with, bite after bite. Perhaps this will help those of us living with us to understand, be more compassionate, and accepting of our adaptations to keep ourselves safe. 
    This column will present a scenario such as the one above, and ask that you comment on how you would navigate it. Let’s talk about it. Let’s share ideas.  Using the example above, here’s the scenario for this issue:
    What would you do?
    Your kind-hearted friend invites you to dinner and insists on cooking for you.  You arrive and the first thing she says is, “I’ve spent all day making this for you. Oh, I bought this salad dressing for you, but you might want to read the ingredients first.”  You do, and it contains malt vinegar.  You look around the kitchen and notice evidence of cross-contamination in the rest of the meal.  What do you do? 
    Please comment below and feel free to share the tricky scenarios that you’ve encountered too.  Let’s discuss how to surmount these social situations.  What would you do?

    Jefferson Adams
    Celiac.com 07/12/2018 - Previous research has shown that the oral administration of Bifidobacterium infantis Natren Life Start super strain (NLS-SS) reduces of gastro-intestinal symptoms in untreated celiac disease patients. The reduction of symptoms was not connected with changes in intestinal permeability or serum levels of cytokines, chemokines, or growth factors. Therefore, researchers suspected that the reduction of symptoms might be related to the modulation of innate immunity.
    To test that hypothesis, a team of researchers set out to assess the potential mechanisms of a probiotic B.infantis Natren Life Start super strain on the mucosal expression of innate immune markers in adult patients with active untreated celiac disease compared with those treated with B. infantis 6 weeks and after 1 year of gluten-free diet.
    The research team included Maria I. Pinto-Sanchez, MD, Edgardo C. Smecuol, MD, Maria P. Temprano,RD, Emilia Sugai, BSBC, Andrea Gonzalez, RD, PhD, Maria L. Moreno,MD, Xianxi Huang, MD, PhD, Premysl Bercik, MD, Ana Cabanne, MD, Horacio Vazquez, MD, Sonia Niveloni, MD, Roberto Mazure, MD, Eduardo Mauriño, MD, Elena F. Verdú, MD, PhD, and Julio C. Bai, MD. They are affiliated with the Medicine Department, Farcombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada; the Small Intestinal Section, Department of Medicine and the Department of Alimentation at Dr. C. Bonorino Udaondo, Gastroenterology Hospital and Research Institute at the Universidad del Salvador in Buenos Aires, Argentina.
    The team determined the numbers of macrophages and Paneth cells, along with the expression of a-defensin-5 expression via immunohistochemistry in duodenal biopsies.
    Their results showed that a gluten-free diet lowers duodenal macrophage counts in celiac disease patients more effectively than B. infantis, while B. infantis lowers Paneth cell counts and reduces expression of a-defensin-5.
    This study documents the differential innate immune effects of treatment with B. infantis compared with 1 year of gluten-free diet. The team calls for further study to better understand the synergistic effects of gluten-free diet and B. infantis supplementation in celiac disease.
    Source:
    J Clin Gastroenterol