Gluten-free Diet in Gluten-genetically Predisposed Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Trieste
Azienda Ospedaliera Spedali Civili di Brescia
University of Eastern Piedmont
Information provided by (Responsible Party):
Ronfani Luca, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00677495
First received: May 12, 2008
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

Undetected or untreated CD may cause severe complications later in life, such as autoimmune disorders.

It is recommended for subjects with autoimmune diseases or at risk for CD to be screened for CD and to repeat serological screening about every three years to detect cases of clinically silent, late-onset CD.

Celiac disease (CD) auto-antibodies against tissue transglutaminase (anti-tTG) are produced in the intestinal mucosa even when not measurable in serum. By using the phage display libraries technique it is possible to investigate in vivo (intestinal biopsy) early antibody responses in autoimmune disease. In particularly, this technique demonstrated that the humoral response against tissue transglutaminase occurs at the intestinal mucosal level, and that the human VH5 gene is the commonly used variable region by the celiac patients to build the anti-tTG. The intestinal mucosa production of IgA anti-tTG could be important in the diagnostic work-up of early-stage CD, when mucosal histology is not yet diagnostic.

The investigators propose to 1) first degree relatives of CD patients, 2) subjects with autoimmune disease, 3) symptomatic subjects (genetically predisposed to gluten intolerance) tested negative for CD related autoantibodies and with apparently normal intestinal mucosa a prospective study to uncover early-stage of gluten intolerance by measuring the mucosal VH5 restricted gene family anti-tTG clones in two biopsies: before and after one year of gluten free-diet (GFD).

Aims of this clinical trial are:

  1. to measure by means of phage display libraries the gluten dependent humoral immune response (anti-tTG) of the intestinal mucosa in subjects with high risk of untreated CD, without CD-related intestinal lesions.
  2. to demonstrate the mucosal gluten-dependent immune response before and after 12 months of gluten-free diet
  3. to demonstrate that dietary intervention might modify the clinical condition (e.g improvements of the gastrointestinal complaints or extra-gastrointestinal symptoms) of the enrolled patients and the improvement of the intestinal inflammation with the disappearance of the mucosal anti-tTG.
  4. to evaluate the specificity of the double staining technique for detecting IgA antitransglutaminase mucosal deposit with the phage display antibodies assay

Condition Intervention
Genetic Predisposition to Disease
Celiac Disease
Dietary Supplement: Gluten-free diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Usefulness of Gluten-free Diet in Gluten-genetically Predisposed Subjects Positive to Intestinal-mucosa Anti-transglutaminase Antibodies

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • Intestinal mucosal gluten-dependent immune response before and after a gluten-free diet [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gluten-free diet Dietary Supplement: Gluten-free diet
Gluten-free diet

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first degree relatives of CD patients
  • subjects with autoimmune disease tested negative for serum anti-tTG but positive for CD related HLA DQ2 or DQ8
  • symptomatic subjects (genetically predisposed to gluten intolerance) tested negative for CD related autoantibodies and with apparently normal intestinal mucosa.

Exclusion criteria:

- None

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00677495

Locations
Italy
IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
University of Trieste
Azienda Ospedaliera Spedali Civili di Brescia
University of Eastern Piedmont
Investigators
Principal Investigator: Fabiana Ziberna IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Serena Vatta IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Stefano Martelossi, MD IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Roberto Marzari University of Trieste
Principal Investigator: Fiorella Florian University of Trieste
Principal Investigator: Vincenzo Villanacci, MD II Pathology Department, Brescia City Hospital, Italy,
Principal Investigator: Daniele Sblattero Department of Medical Sciences, University of Eastern Pidmont, Novara, Italy
Study Chair: Alessandro Ventura, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Tarcisio Not, MD IRCCS Burlo Garofolo, Trieste, Italy
  More Information

Publications:
Responsible Party: Ronfani Luca, MD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00677495     History of Changes
Other Study ID Numbers: RC 25/07
Study First Received: May 12, 2008
Last Updated: April 24, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Burlo Garofolo:
Gluten-free diet
Celiac Disease
Genetic predisposition
Phage display library
Autoimmune diseases

Additional relevant MeSH terms:
Celiac Disease
Genetic Predisposition to Disease
Disease Susceptibility
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014