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  • Jefferson Adams
    Jefferson Adams

    Company Testing Drug That Protects Celiac Sufferers Against Gluten Contamination

    Caption: Photo: CC--winnifredxoxo

    Celiac.com 03/11/2013 - People with celiac disease must follow a gluten-free diet if they want to remain healthy, but a 200-patient study conducted by Alvine Pharmaceuticals show that 90 percent of celiac patients who followed a gluten-free diet still reported symptoms of the disease.

    Photo: CC--winnifredxoxoThat reality is helping to drive an effort by Alvine to develop a drug that would help those people to avoid symptoms and damage that come with accidental exposure to gluten.

    According to a recent press release, Alvine had already raised at least $42 million for its celiac disease drug, and now has $6 million more as it works through a second phase 2 trial.

    The company's top drug prospect is ALV003, a mix of two recombinant gluten-specific proteases that’s designed to be used along with a gluten-free diet to prevent immune reactions associated with celiac disease.

    As disclosed in a recently filed U.S. Securities and Exchange Commission document, the company has raised at least $6 million in debt and other non-equity securities, and could raise up to $500K more.

    ALV003 is designed to be taken orally by people with celiac disease at the time of a meal. It mixes with and breaks down the gluten in food before it can reach the small intestine, where it would cause inflammatory responses.

    The drug is designed to prevent accidental gluten contamination, not to allow celiac sufferers to freely and safely consume large amounts of gluten.

    In a phase 2a study, ALV003 met its goals and reduced gluten-induced intestinal injury in celiac patients who were already following a gluten-free diet. According to clinicaltrial.gov, ALV003 is presently in a study phase with a March 2013 completion date.

    In the fall of 2012, Alvine received permission from the U.S. Food and Drug Administration to fast-track ALV003, which means the company can work more closely with the FDA during clinical trials, and may get a faster review if they file a New Drug Application.

    Alvine is a San Carlos, California-based biopharmaceutical company founded in 2006 on technology from Stanford University. Its investors include Abbott Biotech Ventures, Panorama Capital, InterWest Partners, Prospect Venture Partners, Sofinnova Ventures, Black River Asset Management and Flagship Ventures.

    Read more here.


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    Guest Gluten Free Foodies

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    Oh dear. We need to get away from the idea of popping a pill to solve our problems. Big pharma is only interested in profits, not health.

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    I don't like the idea of pill popping any more than the next person, but I find the cross contamination issue in our food chain to be an insurmountable obstacle in trying to be gluten-free. My main celiac symptom is a rash that is very sensitive to gluten. In spite of eating a very clean diet and almost never eating out, I have a few small blisters almost all the time. I find that eating things like nuts or quinoa (or anything really) can cause a break out, even though the packaging doesn't declare a shared equipment situation. I would bet that most people are getting more gluten than they realize and just don't have the sensitive detection system I have. (I call it my canary in the mine.) If there were a pill that could clean up the small amounts of gluten in food, it would certainly make my life easier and maybe help those that believe they are eating gluten-free but still have unexplained symptoms.

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    This claim has been around for years - I remember going to a seminar back when I was diagnosed in 2007. Never seems to actually go anywhere though.

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    Pharmaceuticals definitely make the world a better place, the problem is how they are marketed and abused by people. I am celiac and have been gluten-free for a few years now, but it's almost impossible to avoid accidental glutening and cross-contamination, even though I have drastically altered my life. I, for one, would welcome something that would help me from accidental gluten ingestion. Then I could actually occasionally go out to dinner, etc. without it being such a stress-filled game of Russian roulette. If we don't encourage companies to do research, it will never happen.

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    I don't like the idea of pill popping any more than the next person, but I find the cross contamination issue in our food chain to be an insurmountable obstacle in trying to be gluten-free. My main celiac symptom is a rash that is very sensitive to gluten. In spite of eating a very clean diet and almost never eating out, I have a few small blisters almost all the time. I find that eating things like nuts or quinoa (or anything really) can cause a break out, even though the packaging doesn't declare a shared equipment situation. I would bet that most people are getting more gluten than they realize and just don't have the sensitive detection system I have. (I call it my canary in the mine.) If there were a pill that could clean up the small amounts of gluten in food, it would certainly make my life easier and maybe help those that believe they are eating gluten-free but still have unexplained symptoms.

    I agree with you. Despite being very careful, including keeping my home gluten-free, with lab tests and endoscopy that have normalized on a gluten-free diet, I still often have symptoms. My son also has celiac disease, and since I am so sensitive to tiny bits of cross-contamination, I jokingly say that I can test foods out for him and tell him if they're safe (or not).

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    I agree with Sue. There is lots of cross contamination in most foods. I take digestive enzymes and probiotics with almost every meal. It really helps. If this pill (proteaze enzymes) can help digest the minute amounts of gluten that we inadvertently, accidentally eat, I am all for it. The article states that it is not so Celiac people will be able to eat large amounts of gluten. It is about time for this to happen!

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    I doubt if the naysayers here would tell their doctor "no thanks, I don't need antibiotics for this infection", "no treatment for my breast cancer thank you", "my child's ear infection will clear up on its own". If you don't like "popping pills," good for you. But thank God there are greedy researchers out there trying to help those that need and want treatments to help their suffering.

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    My symptoms continued until I eliminated xanthum gum from my diet in addition to being gluten-free, and my gut permeability finally improved. I am pretty healthy these days and thankful that someone alerted me to the potential problem with xanthum gum, which they seem to put in ALL the gluten-free products these days. I even found it in pineapple juice and moisturizers. Doctors remain ignorant about the allergenic effects of xanthum gum.

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    My symptoms continued until I eliminated xanthum gum from my diet in addition to being gluten-free, and my gut permeability finally improved. I am pretty healthy these days and thankful that someone alerted me to the potential problem with xanthum gum, which they seem to put in ALL the gluten-free products these days. I even found it in pineapple juice and moisturizers. Doctors remain ignorant about the allergenic effects of xanthum gum.

    Why are you suggesting that doctors are "ignorant"? If you have found a cause for your symptoms, that is good. For most people with celiac disease, xantham gum is considered to be permitted.

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    I'm all for it as well. If a person doesn't want to take them, more power to you. Don't take them. But for people who want to see if something can improve their symptoms and quality of life - they should have the right to try it.

     

    I also take probiotics every day and digestive enzymes with every meal. I don't know how I would get by without them. I was a sickly human being before I discovered those, and I discovered them 20 years before I got a diagnosis of celiac disease. Those pills kept me alive and relatively healthy.

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    Apparently I am in the minority, but just like people take medicine for type 1 diabetes, I would take medicine for celiac disease.

    I would be happy to take pill - medicine or probiotic - so I could safely eat a meal out. I would also happily take medicine so I could eat a piece of my children's birthday cake with them. If you don't want to take pills, awesome, don't. If you don't want to read about medicine being developed for celiac disease, don't.

    I am happy to read about advances, research, and possible medication to keep my auto immune disease from hurting me!

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  • About Me

    Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

  • Related Articles

    Jefferson Adams
    Celiac.com 05/15/2009 - Certain proteins found in the gluten of wheat, rye and barley trigger adverse responses in people with gluten intolerance and celiac disease. This happens when the offending gluten proteins encounter the immune systems of susceptible individuals, triggering a CD4+ T-cell mediated immune response, together with inflammation of the small intestine. However, a number of gluten proteins contain no T-cell stimulatory epitopes, and so trigger no such adverse immune response. So, not all gluten is equally offensive to celiacs, and some may be both well tolerated and useful for making better bread.
    Gluten proteins are found in multiple gene sites on chromosomes 1 and 6 of the three different genomes of hexaploid bread wheat (Triticum aestivum) (AABBDD).
    Gluten is the stuff that makes bread delightfully chewy, among other desirable properties, so being able to successfully incorporate non-offending gluten into bread recipes might yield better breads that are safe for consumption by folks with celiac disease. Obviously, being able to produce high-quality, celiac-safe bread on a commercial scale would be of tremendous benefit for both producers and consumers. Currently, most gluten-free bread contains no gluten, as it has been difficult or impractical to separate the offending proteins from the non-offending proteins.
    Recently, a team of researchers based in the Netherlands attempted to  remove celiac disease-related protein from Chinese Spring wheat while maintaining the beneficial bread-baking properties.
    The team was made up of Hetty C. van den Broeck, Teun W. J. M. van Herpen, Cees Schuit, Elma M. J. Salentijn, Liesbeth Dekking, Dirk Bosch, Rob J. Hamer, Marinus J. M. Smulders, Ludovicus J. W. J. Gilissen and Ingrid M. van der Meer.
    The team used a set of deletion lines of Triticum aestivum cv. Chinese Spring to assess the results of removing individual gluten sites on both the level of the T-cell stimulatory epitope in the gluten proteome and the favorable qualities of the flour.
    To measure the reduction of T-cell stimulatory epitopes, the team used monoclonal antibodies that recognize T-cell epitopes contained in gluten proteins. They then clinically tested the deletion lines for their dough mixing properties and dough composition.
    The team's attempts to remove the alpha-gliadin site from the short arm of chromosome 6 of the D-genome (6DS) yielded in a favorable decrease in the presence of T-cell stimulatory epitopes, but also yielded a significantly loss of favorable baking properties.
    However, by deleting the omega-gliadin, gamma-gliadin, and LMW-GS locations from the short arm of chromosome 1 of the D-genome (1DS), researchers were able to strip offending T-cell stimulatory epitopes from the proteome while maintaining technological properties.
    The team concludes that their data hold important implications for lowering the quantity of T-cell stimulatory epitopes in wheat, and promoting the creation of celiac-safe wheat varieties that will potentially yield breads of higher quality than currently available.

    BMC Plant Biology 2009, 9:41
     

    Jefferson Adams
    Can Video Capsule Endoscopy Diagnose Celiac Disease When Esophogastroduodenoscopy (EGD) and Biopsy Fail?
    Celiac.com 12/10/2012 - In celiac disease, doctors use video capsule endoscopy (VCE) mainly to follow-up on stubborn cases, and to diagnose adenocarcinoma, lymphoma or refractory celiac disease. However, some doctors are suggesting that VCE could replace standard esophagogastroduodenoscopy (EGD) and biopsy in certain circumstances.
    A team of researchers recently evaluated the use of VCE to diagnose celiac disease in place of esophagogastroduodenoscopy (EGD) and biopsy under certain circumstances.
    The research team included Matthew S. Chang, Moshe Rubin, Suzanne K Lewis, and Peter H. Green. They are variously affiliated with the Celiac Disease Center, Division of Digestive and Liver Diseases of the Department of Medicine at Columbia University College of Physicians and Surgeons in New York, and with the Division of Gastroenterology and Hepatology of the Department of Medicine at New York Hospital Queens, Weill Cornell Medical College in Flushing, New York.
    For their study, the team evaluated eight patients with suspected celiac disease who were diagnosed by VCE.
    Of the eight patients, four underwent EGD and biopsy, with negative biopsy results. Two patients declined the procedure, and two showed contradictory results due to hemophilia and von Willebrand disease.
    Using VCE, the team found that all patients showed mucosal scalloping, mucosal mosaicism and reduced folds in either the duodenum or jejunum.
    After treatment with a gluten-free diet, seven patients who participated in follow-up showed improvement in either their blood tests, or their presenting clinical symptoms.
    From this small study, the team concludes that VCE and the observation of the classic mucosal changes of villous atrophy may replace biopsy as the mode of diagnosis for celiac disease in patients who either decline EGD, or show contradictory results, or in suspect patients with negative duodenal biopsy.
    They encourage further study to determine the role and cost of using VCE to diagnose celiac disease.
    Source:
    BMC Gastroenterolohy. 2012;12(90)

    Jefferson Adams
    Non-Celiac Gluten Sensitivity Not Holding Up to Scrutiny
    Celiac.com 08/25/2014 - Numerous people without celiac disease claim to suffer from celiac-like gastrointestinal symptoms when they consume wheat, rye or barley products, and claim that avoiding these products makes them feel better. However, even though many people make this claim, this is largely a self-reported condition. Some data have supported the idea of gluten sensitivity, but the most recent and more complete data seem to indicate that the real culprit might not be gluten, but fermentable, poorly absorbed short-chain carbohydrates known as FODMAPs.
    In fact the same researcher whose early data supported the idea of non-celiac gluten sensitivity also headed the follow-up study that showed no effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates.
    In this third study, that researcher, Peter Gibson at Monash University in Canada set out to assess patients who believe they have NCGS. The study team included Jessica R. Biesiekierski, PhD, RN; Evan D. Newnham, MD, FRACP; Susan J. Shepherd, PhD, APD; Jane G. Muir, PhD, APD; and Peter R. Gibson, MD, FRACP. They are variously affiliated with the Department of Gastroenterology, Eastern Health Clinical School, and the Department of Gastroenterology, Central Clinical School at Monash University, The Alfred Hospital in Melbourne, Australia, and with the Translational Research Center for Gastrointestinal Disorders, Herestraat in Leuven, Belgium.
    The team put out advertisements calling for adults who believed they had non-celiac gluten sensitivity (NCGS) and were willing to participate in a clinical trial. Respondents were asked to complete a questionnaire about symptoms, diet, and celiac investigation. They received 248 responses, and completed surveys on a total of 147 people. There were 17 men and 130 women, averaging 43.5 years of age.
    The team eliminated seventy-two percent of the respondents for inadequate exclusion of celiac disease (62%), uncontrolled symptoms despite gluten restriction (24%), and not following a GFD (27%), alone or in combination. A full 15% of respondents had received no testing or examination for celiac disease.
    Gluten avoidance was self-initiated in nearly half of respondents; while it was prescribed by alternative health professionals in 21%, by dietitians in 19%, and by general practitioners in 16%.
    Of 75 respondents who had received duodenal biopsies, nearly one-third had no gluten intake, or inadequate gluten intake, at the time of endoscopy. Inadequate celiac investigation was most common if gluten-avoidance was self-initiated (69%), alternative health professionals (70%), general practitioners (46%), or dietitians (43%).
    A total of 40 respondents fulfilled criteria for NCGS. Those folks showed excellent knowledge of and adherence to a gluten-free diet. However, a full 65% of those who met criteria for NCGS showed intolerance to other foods.
    Just over 1 in 4 respondents self-reporting as NCGS fulfill criteria for its diagnosis, while gluten-avoidance without adequate exclusion of celiac disease is common.
    In 75% of respondents, symptoms are poorly controlled despite gluten avoidance. These results also stress the importance of testing for other food sensitivities, and of celiac screening and evaluation for those people claiming non-celiac gluten-sensitivity.
    Clearly, more study needs to be done to determine if non-celiac gluten sensitivity exists, or if there are other possible causes for the symptoms.
    Sources:
    Nutr Clin Pract August 2014 vol. 29 no. 4 504-509 doi: 10.1177/0884533614529163 Gastroenterology. 2013 Aug;145(2):320-8.e1-3. doi: 10.1053/j.gastro.2013.04.051.  
    The team put out advertisements calling for adults who believed they had non-celiac gluten sensitivity (NCGS) and were willing to participate in a clinical trial. Respondents were asked to complete a questionnaire about symptoms, diet, and celiac investigation. They received 248 responses, and completed surveys on a total of 147 people. There were 17 men and 130 women, averaging 43.5 years of age.
     

    Jefferson Adams
    Celiac.com 06/11/2015 - Non-celiac gluten sensitivity (NCGS) is a somewhat controversial emerging disorder. There is no current medical consensus regarding its criteria, and study data have been inconclusive.
    Many alternative health practitioners recommend gluten-free diets for people who claim to be sensitive to gluten, but do not have celiac disease. Despite numerous reports of people without celiac disease experiencing celiac-like symptoms when eating gluten, there are currently no clear diagnostic guidelines for NCGS. NCGS is still diagnosed by excluding celiac disease, and finding no reliable celiac biomarkers.
    A team of researchers recently set out to evaluate the prevalence, diagnostic exclusion of celiac disease and the efficacy of a gluten-free diet (GFD) for NCGS patients.
    The research team included J. Molina-Infante; S. Santolaria; D. S. Sanders; and F. Fernández-Bañares. They are variously affiliated with the Department of Gastroenterology, Hospital San Pedro de Alcantara, Caceres, Spain, the Department of Gastroenterology, Hospital San Jorge, Huesca, Spain, the Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK, the Department of Gastroenterology, Hospital Universitario Mutua Terrassa, Barcelona, Spain, and with CIBERehd, Barcelona, Spain.
    Their team conducted a PubMed search through December 2014. They defined NCGS as self-reported gluten intolerance, negative celiac serology and absence of villous atrophy. They also included studies evaluating the impact of a GFD on patients with irritable bowel syndrome (IBS).
    They found that rates of NCGS (0.5–13%) varied considerably. Seventeen studies met the inclusion criteria for NCGS. The studies included 1561 patients, 26 of whom were children. HLA haplotypes could not be linked to histology, either by normal or lymphocytic enteritis (LE)] in 1,123 NCGS patients. Nearly half (44%) of NCGS patients tested positive for HLADQ2/DQ8 haplotypes.
    Using advanced diagnostic techniques that combine LE and HLADQ2/DQ8 haplotypes, the team reclassified 39 (20%) of 189 NCGS cases as celiac disease.
    They found a higher than expected family history of celiac disease and autoimmune disorders in NCGS patients. For HLADQ2 positive diarrhea-predominant IBS patients, a GFD resulted in variable, but significantly improved stool frequency.
    Rates of NCGS are extremely variable. A subset of NCGS patients might actually be part of what many researchers refer to as celiac disease "light."
    The long term benefit of a gluten-free diet for NCGS patients is currently unclear, but certainly the diet, if well-balanced, would not cause any issues. The researchers do note that HLADQ2 positive diarrhea-type IBS patients might gain symptom improvement from a gluten-free diet.
    Clearly more studies are needed to determine if NCGS is a bona fide medical condition, as many suspect. Until then, there is very little treatment available from medical practitioners, and many people with self-diagnosed NCGS will doubtless be left to self-treatment. For many, this will include avoiding gluten.
    Do you, a loved one, or someone you know have gluten-sensitivity without celiac disease? Share your thoughts and comments below.
    Source:
     Aliment Pharmacol Ther. 2015;41(9):807-820.

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