HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100099
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : September 19, 2012
South-Eastern Norway Regional Health Authority
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Celiac Disease Gluten Dietary Supplement: Gluten challenge. Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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.

Primary Outcome Measures :
  1. HLA-DQ2-tetramer response after gluten challenge [ Time Frame: 6 days. ]
    FACS analysis of peripheral blood after gluten challenge.

Secondary Outcome Measures :
  1. Mucosal responses to 3 day gluten challenge. [ Time Frame: 4 days. ]
    Biopsy the fourth day of gluten challenge.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01100099

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

Responsible Party: Oslo University Hospital Identifier: NCT01100099     History of Changes
Other Study ID Numbers: 2007068
2007068 2009021 ( Other Identifier: Health Administration of Eastern Norway )
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

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