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Celiac.com 10/23/2015 - Just as I finished writing about the failure of current commercial enzymes to effectively degrade gluten, an interesting study on another enzyme suggests that there may be help on the horizon, at least for people without celiac disease. According to the latest press release, in lab conditions, aspergillus niger prolyl endoprotease (AN-PEP) efficiently degrades gluten molecules into non-immunogenic peptides. But so what? If AN-PEP is to be effective in people with celiac disease or gluten-sensitivity, which would seem to be the whole point of an anti-gluten enzyme, it must effectively digest gluten in "non-healthy" subjects. A team of researchers recently set out to assess AN-PEP on gluten degradation in a low and high calorie meal in healthy subjects. The research team included B.N. Salden, V. Monserrat, F.J. Troost, M.J. Bruins, L. Edens, R. Bartholomé, G.R. Haenen, B. Winkens, F. Koning, A.A. Masclee. They are variously affiliated with the Division of Gastroenterology-Hepatology in the Department of Internal Medicine at NUTRIM, Maastricht University Medical Center, Maastricht, the Department of Immunohematology and Blood Transfusion at Leiden University Medical Centre in Leiden, the DSM Biotechnology Centre, Delft, the Department of Pharmacology and Toxicology, CARIM, at Maastricht University in Maastricht, and with the Department of Methodology and Statistics, CAPHRI, Maastricht University Medical Center in Maastricht, all in The Netherlands. The team conducted a randomized, double-blind, placebo-controlled, cross-over study in which 12 healthy volunteers attended to four test days. Each volunteer received a liquid low or high calorie meal (4 g gluten) with AN-PEP or placebo administered into the stomach. Using a triple-lumen catheter the team was able to sample gastric and duodenal aspirates, as polyethylene glycol (PEG)-3350 was continuously infused. Acetaminophen in the meals tracked gastric emptying time. The team used gastric and duodenal samples to calculate 240-min area under the curve (AUC0-240 min ) of α-gliadin concentrations. The team calculated absolute α-gliadin AUC0-240 min using duodenal PEG-3350 concentrations. The teams data showed that AN-PEP lowered α-gliadin concentration AUC0-240 min, compared to placebo, from low and high calorie meals in stomach (low: 35 vs. 389 μg × min/mL; high: 53 vs. 386 μg × min/mL; P < 0.001) and duodenum (low: 7 vs. 168 μg × min/mL; high: 4 vs. 32 μg × min/mL; P < 0.001) and absolute α-gliadin AUC0-240 min in the duodenum from low (2813 vs. 31 952 μg × min; P < 0.001) and high (2553 vs. 13 095 μg × min; P = 0.013) calorie meals. In the placebo group, the high compared to low calorie meal slowed gastric emptying and lowered the duodenal α-gliadin concentration AUC0-240 min (32 vs. 168 μg × min/mL; P = 0.001). These results confirm that AN-PEP significantly enhanced gluten digestion in the stomach of healthy volunteers, while increasing caloric density prolonged gastric residence time of the meal. According to the authors, these results suggest that AN-PEP shows promise as an anti-gluten digestive enzyme for people with celiac disease, but further study is clearly needed. Still, the fact that AN-PEP can effectively break down gluten in the stomach of healthy volunteers is a good start, but it means little if AN-PEP can’t do the same in people with celiac disease, which remains to be seen. Stay tuned for more developments. Source: Aliment Pharmacol Ther. 2015 Aug;42(3):273-85. doi: 10.1111/apt.13266. Epub 2015 Jun 4.
Celiac.com 11/25/2003 - Investigators from the Celiac Sprue Research Foundation, a non-profit public charity, and the Palo Alto Medical Foundation are seeking 20 volunteers who have Celiac Sprue to participate in a study called the "Gluten Detoxification Trial". The Gluten Detoxification Trial will test the effects of consumption of an Orange Juice Mixture that has been modified by the addition of gluten pre-treated with an enzyme (PEP) that is intended to "detoxify" the gluten. If the PEP is successful in detoxifying the gluten, then the stage will be set for development of a PEP therapeutic drug, or pill, that may allow Celiac Sprue patients to consume a regular gluten containing diet. The study involves 2 two-week stages, separated by one month off. The first stage will occur during the first two weeks in December. The second stage will occur during late January 2004. Participants in this study will be randomized to consume an Orange Juice Mixture containing gluten daily for 14 days during one stage, and an Orange Juice Mixture containing gluten pre-treated with the PEP daily for 14 days during the other stage. Participants will record symptoms daily during each stage, and will have laboratory tests measured before and after each stage. Participants will undergo a screening physical exam at the beginning, and brief follow-up exams after each stage at the Palo Alto Medical Foundation. Participants in the Gluten Detoxification Trial must meet all of the following criteria: Diagnosed with Celiac Sprue by small intestinal biopsy (participants must be able to provide a copy of the biopsy report). Have had at least one abnormal Celiac antibody test (e.g. transglutaminase (ttg), endomysial (EMA), anti-gliadin) in the past. Be in remission on a gluten-free diet. Be at least 18 years of age. Pre-registration is required to participate in the study. If you can participate, please contact the Celiac Sprue Research Foundation at the above address or e-mail address and request a registration packet/consent. Please call either Dr. Gail Pyle at (408) 655-0384 or Dr. Gary Gray at (650) 327-1144 if you have any questions.
Celiac.com 03/19/2002 - For the past several years, Gary M. Gray, M.D. and Chaitan Khosla, Ph.D., both at Stanford University, have been studying the underlying causes of Celiac Disease, with an eye toward finding a therapeutic solution that would not require the strict adherence to a gluten-free diet. For the past two years, I have helped organize the Celiac conference at Stanford University; and we have collected blood from Celiac volunteers for their research. Based on a series of studies involving animal tissue, Drs. Gray, Khosla, and coworkers have developed a hypothesis for the cause of the disease. Their findings in animal studies need to be confirmed on human tissue, and any differences in normal and Celiac intestine must be defined. The Stanford researchers are now in need of volunteers who are scheduled for a follow-up biopsy as part of their optimal care to provide intestinal tissue samples. Volunteers must be biopsy-diagnosed Celiacs who, as part of their care, will be undergoing an upper gastrointestinal endoscopy for recovery of small biopsies from the duodenum. For this research, two small (a few milligrams) of additional tissue will be taken during the biopsy, frozen immediately, and transported to Stanford. Please note that volunteers undergoing procedures at locations other than Stanford Hospital could participate. The small amount of additional tissue does not constitute a significant additional risk over and above that you will undergo due to the endoscopy and routine biopsies for the pathologist to examine. The research has been approved by the Human Subjects Committee at Stanford University Medical Center. If you would like to participate in this study, please contact Kelly Rohlfs at 650-725-4771 or email@example.com.If you have questions concerning the risks and benefits of this study, please contact Dr. Gray at 650-725-3366 or firstname.lastname@example.org. Dr. Gray will coordinate the study with your gastroenterologist at the time of your endoscopy.