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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2005-03-31

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

Keywords

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Celiac Disease Gluten Toxicity Small bowel morphometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Gluten (behaviour)

Intervention Type BEHAVIORAL

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

1. patients younger than 18 years old;
2. poor compliance to the gluten-free diet;
3. abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
4. associated conditions, such as selective IgA deficiency or other autoimmune diseases -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Carlo Catassi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy

Locations

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University Department of Pediatrics

Ancona, Ancona, Italy

Site Status

Countries

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Italy

Other Identifiers

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IRB-2000-611

Identifier Type: -

Identifier Source: org_study_id