HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

This study has been completed.
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01100099
First received: April 6, 2010
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

The investigators will evaluate the use of an HLA-DQ2-gliadin tetramer for staining of gluten specific T cells in the diagnostics of uncertain celiac disease. Some patients have started on a gluten free diet without a diagnosis of celiac disease. Subsequent later investigation in special care is difficult as the patients often are reluctant to prolonged gluten challenge. The investigators use the HLA-DQ2-gliadin tetramers for detection of gluten specific T cells after a short gluten challenge. By this method the investigators search to discriminate between true celiac disease and clinical gluten intolerance without celiac disease, in a population of HLA-DQ2+ persons already on a gluten free diet without a formal diagnosis of celiac disease.


Condition Intervention Phase
Celiac Disease
Gluten
Dietary Supplement: Gluten challenge.
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • HLA-DQ2-tetramer response after gluten challenge [ Time Frame: 6 days. ] [ Designated as safety issue: No ]
    FACS analysis of peripheral blood after gluten challenge.


Secondary Outcome Measures:
  • Mucosal responses to 3 day gluten challenge. [ Time Frame: 4 days. ] [ Designated as safety issue: No ]
    Biopsy the fourth day of gluten challenge.


Enrollment: 100
Study Start Date: September 2006
Study Completion Date: September 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gluten challenge.
Diagnosis of celiac disease. Before and after a gluten challenge small bowel biopsies will be taken, and blood samples will be drawn for tetramer staining of gluten specific T cells.
Dietary Supplement: Gluten challenge.
The study population consists of 50 HLA-DQ2+ patients on a gluten free diet, both celiacs and uncertain celiacs. The patients will undergo a oral gluten challenge with four slices of bread daily for three days. Before challenge blood samples will be drawn for tetramer staining of gluten-specific T-cells. The analysis is done at the Institute of Immunology at Rikshospitalet, using FACS analysis. Small intestinal biopsies will be examined for morhological changes and inflammatory gene expression. These procedures with blood samples and biopsies will be repeated after gluten challenge. Registration for clinical symptoms and personality traits will be done by standardised and validated forms. A dietist will perform an interview of the patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HLA-DQ2+ celiacs and HLA-DQ2+ persons who have been on a gluten free diet for at least 4 weeks.

Exclusion Criteria:Pregnancy

  • Other severe disease
  • Refusal to participate
  • HLA-DQ2 negativity
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01100099

Locations
Norway
Department of Medicine, Endoscopy Unit, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
University of Oslo
  More Information

Publications:
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01100099     History of Changes
Other Study ID Numbers: 2007068, 2007068 2009021
Study First Received: April 6, 2010
Last Updated: September 18, 2012
Health Authority: Norway: Ministry of Health and Care Services

Keywords provided by Oslo University Hospital:
Celiac disease.
Food intolerance.
Gluten intolerance without celiac disease.

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

ClinicalTrials.gov processed this record on July 10, 2014