<<Disclaimer: Verify this information before applying it to your situation.>>

Sept. 12, 2003
From:  Celiac Sprue Research Foundation,  P.O. Box 61193 ,  Palo Alto, CA
94306-1193 , Fax (650)-251-9865 , www.celiacsprue.org

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 last two weeks in October. The second stage
will occur during the first two weeks in December. 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 of
October, and brief follow-up exams after each stage at the Palo Alto
Medical Foundation. Participants need to drive to the Palo Alto Medical
Foundation, San Francisco Bay Area, California, approximately 4-5 times
during the study.
Participants in the Gluten Detoxification Trial must meet all of the
following criteria:
1. Diagnosed with Celiac Sprue by small intestinal biopsy (participants
must be able to provide a copy of the biopsy report).
2. Have had at least one abnormal Celiac antibody test (e.g.
transglutaminase (ttg), endomysial (EMA), anti-gliadin) in the past.
3. Be in remission on a gluten-free diet.
4. 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.  Initial screening will take place Oct. 1-3, 2003.
Please call either Dr. Gail Pyle at (408) 655-0384 (or email:
[log in to unmask]) or Dr. Gary Gray at (650) 327-1144
([log in to unmask]) if you have any questions.
Thank you.

*Support summarization of posts, reply to the SENDER not the CELIAC List*