Status:
TERMINATED
Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease
Lead Sponsor:
Università Politecnica delle Marche
Collaborating Sponsors:
Associazione Italiana Celiachia (AIC)
Conditions:
Celiac Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten.
Detailed Description
Treatment of celiac disease (CD) is based on the complete avoidance of gluten-containing products in the diet. However it is not known whether tiny amounts of gluten are harmful for patients on long-t...
Eligibility Criteria
Inclusion
- adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health -
Exclusion
- patients younger than 18 years old;
- poor compliance to the gluten-free diet;
- abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
- associated conditions, such as selective IgA deficiency or other autoimmune diseases -
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00250146
Start Date
February 1 2001
End Date
March 1 2005
Last Update
November 7 2005
Active Locations (1)
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1
University Department of Pediatrics
Ancona, Ancona, Italy, 60123