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From:
Kelly Rohlfs <[log in to unmask]>
Reply To:
Kelly Rohlfs <[log in to unmask]>
Date:
Thu, 12 Jun 2003 19:54:56 -0700
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<<Disclaimer: Verify this information before applying it to your situation.>>

Celiac Sprue Research Foundation
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 8
volunteers who have Celiac Sprue to participate in a study called the
"Gluten Detoxification Pre-Trial Study" that will be a precursor to a
larger study called the "Gluten Detoxification Trial" scheduled for later
this year.  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 purpose of the Pre-Trial Study is to answer two questions that are
critical in designing the Gluten Detoxification Trial: 1) What dose of
gluten should be used? and 2) What laboratory tests should be monitored
during the trial?  The study is scheduled to begin at the end of June and
will require participation over a 5-week period of time.  Participants in
this study will consume an Orange Juice Mixture containing gluten daily for
21 days.  Participants will record symptoms daily, and laboratory tests
will be measured before, during, and immediately after the
study.  Participants in this Pre-Trial Study will not be able to
participate in the subsequent Gluten Detoxification Trial.

Participants in the Pre-Trial Study 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.

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.

* Please remember some posters may be WHEAT-FREE, but not GLUTEN-FREE *

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