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

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 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:
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.

5.  Be able to travel to Palo Alto, California several times during the
study.  We may be able to help with travel costs to fly in for the day from
Southern California, Oregon or Nevada areas.

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 email:
[log in to unmask]) or Dr. Gary Gray at (650) 327-1144
([log in to unmask]) if you have any questions.

* Visit the Celiac Web Page at www.enabling.org/ia/celiac/index.html *