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

Celiac Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00250146
• Other study ID #: IRB-2000-611
• Status: Terminated
• Phase: N/A
• First received: November 3, 2005
• Last updated: November 3, 2005
• Start date: February 2001
• Est. completion date: March 2005

Study information

• Verified date: April 2005
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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-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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Behavioral:
• Gluten (behaviour)

Locations

Country	Name	City	State
Italy	University Department of Pediatrics	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Università Politecnica delle Marche	Associazione Italiana Celiachia (AIC)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Villous Height/Crypt Depth ratio on small intestinal biopsy
Primary	Intraepithelial lymphocyte coun on small intestinal biopsy
Primary	changes in serum IgA class anti-trasnglutaminase antibodies
Primary	changes in serum IgG class anti-gliadin antibodies
Primary	clinical symptoms