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.