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.
Please call either Dr. Gail Pyle at (408) 655-0384 or Dr. Gary Gray at (650) 327-1144 if you have any questions.