Gluten-free Diet in Gluten-genetically Predisposed Subjects
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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:
- 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.
- to demonstrate the mucosal gluten-dependent immune response before and after 12 months of gluten-free diet
- 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.
- 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 |
- Intestinal mucosal gluten-dependent immune response before and after a gluten-free diet [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 27 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (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 |
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.
Contacts and Locations| Contact: Tarcisio Not, MD | 39-040-378-5472 | not@burlo.trieste.it |
| Italy | |
| IRCCS Burlo Garofolo | Recruiting |
| Trieste, Friuli Venezia Giulia, Italy, 34137 | |
| Contact: Tarcisio Not, MD +39 040 3785472 not@burlo.trieste.it | |
| 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: | Tarcisio Not, 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: | September 1, 2011 |
| 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 Disease Susceptibility Genetic Predisposition to Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013