HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

University of Oslo (UIO)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Celiac Disease; Gluten

Treatments: Dietary Supplement: Gluten challenge.

Study type: Interventional

Funder types: Other

Identifiers

NCT01100099

2007068

2007068 2009021 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Gluten challenge.

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Gluten challenge.