HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

September 18, 2012 updated by: Oslo University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Department of Medicine, Endoscopy Unit, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HLA-DQ2-tetramer response after gluten challenge
Time Frame: 6 days.
FACS analysis of peripheral blood after gluten challenge.
6 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal responses to 3 day gluten challenge.
Time Frame: 4 days.
Biopsy the fourth day of gluten challenge.
4 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
South-Eastern Norway Regional Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 6, 2010

First Submitted That Met QC Criteria

April 7, 2010

First Posted (Estimate)

April 8, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007068
  • 2007068 2009021 (Other Identifier: Health Administration of Eastern Norway)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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