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Gluten-free Diet in Gluten-genetically Predisposed Subjects

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ClinicalTrials.gov Identifier: NCT00677495
Recruitment Status : Active, not recruiting
First Posted : May 14, 2008
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
University of Trieste
Azienda Ospedaliera Spedali Civili di Brescia
University of Eastern Piedmont
Information provided by (Responsible Party):
Luca Ronfani, IRCCS Burlo Garofolo

Brief Summary:

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 or disease Intervention/treatment Phase
Genetic Predisposition to Disease Celiac Disease Dietary Supplement: Gluten-free diet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Usefulness of Gluten-free Diet in Gluten-genetically Predisposed Subjects Positive to Intestinal-mucosa Anti-transglutaminase Antibodies
Actual Study Start Date : May 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Gluten-free diet
Gluten-free diet
Dietary Supplement: Gluten-free diet
Gluten-free diet




Primary Outcome Measures :
  1. Intestinal mucosal gluten-dependent immune response before and after a gluten-free diet [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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


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 ClinicalTrials.gov identifier (NCT number): 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 Azienda Ospedaliera Spedali Civili di Brescia
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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luca Ronfani, MD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00677495     History of Changes
Other Study ID Numbers: RC 25/07
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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