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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250146
Recruitment Status : Terminated
First Posted : November 7, 2005
Last Update Posted : November 7, 2005
Associazione Italiana Celiachia (AIC)
Information provided by:
Università Politecnica delle Marche

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.

Condition or disease Intervention/treatment Phase
Celiac Disease Behavioral: Gluten (behaviour) Not Applicable

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-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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Study Start Date : February 2001
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Primary Outcome Measures :
  1. Villous Height/Crypt Depth ratio on small intestinal biopsy
  2. Intraepithelial lymphocyte coun on small intestinal biopsy
  3. changes in serum IgA class anti-trasnglutaminase antibodies
  4. changes in serum IgG class anti-gliadin antibodies
  5. clinical symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250146

University Department of Pediatrics
Ancona, Italy, 60123
Sponsors and Collaborators
Università Politecnica delle Marche
Associazione Italiana Celiachia (AIC)
Principal Investigator: Carlo Catassi, M.D. Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy Identifier: NCT00250146     History of Changes
Other Study ID Numbers: IRB-2000-611
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: November 7, 2005
Last Verified: April 2005

Keywords provided by Università Politecnica delle Marche:
Celiac Disease
Small bowel morphometry

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases