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

This study has been terminated.
Sponsor:
Collaborator:
Associazione Italiana Celiachia (AIC)
Information provided by:
Università Politecnica delle Marche
ClinicalTrials.gov Identifier:
NCT00250146
First received: November 3, 2005
Last updated: NA
Last verified: April 2005
History: No changes posted
  Purpose

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 Intervention
Celiac Disease
Behavioral: Gluten (behaviour)

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

Resource links provided by NLM:


Further study details as provided by Università Politecnica delle Marche:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 39
Study Start Date: February 2001
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250146

Locations
Italy
University Department of Pediatrics
Ancona, Italy, 60123
Sponsors and Collaborators
Università Politecnica delle Marche
Associazione Italiana Celiachia (AIC)
Investigators
Principal Investigator: Carlo Catassi, M.D. Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250146     History of Changes
Other Study ID Numbers: IRB-2000-611
Study First Received: November 3, 2005
Last Updated: November 3, 2005
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014