Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease

Study Overview
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Brief Summary
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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
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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-term treatment. This is an important issue, as even a strict gluten-free diet (GFD) is usually contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated CD patients. This is a prospective, placebo-controlled, double-blind study. Patients are adults with biopsy-proven CD on treatment with the GFD for at least 2 years. During the study period their background daily gluten intake is kept lower than 5 mg. After baseline evaluation, patients continue their GFD and are assigned to ingest 0 mg, 10 mg or 50 mg of daily gluten (incorporated in a capsule) for 90 days. The following evaluations are performed both at baseline and after the micro-challenge: clinical, serological (anti-transglutaminase and antigliadin antibodies), and small intestine histology.

Conditions
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Celiac Disease

Intervention / Treatment
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* Behavioral: Gluten (behaviour)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Gluten (behaviour)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Villous Height/Crypt Depth ratio on small intestinal biopsy |  |  | 
| Intraepithelial lymphocyte coun on small intestinal biopsy |  |  | 
| changes in serum IgA class anti-trasnglutaminase antibodies |  |  | 
| changes in serum IgG class anti-gliadin antibodies |  |  | 
| clinical symptoms |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac Disease, Gluten, Toxicity, Small bowel morphometry