HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

Phase 2

Completed

• Conditions: Celiac Disease; Gluten
• Interventions: Dietary Supplement: Gluten challenge.

• Registration Number: NCT01100099
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2009-12
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gluten challenge.	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.

Primary Outcome Measures

Name	Time	Method
HLA-DQ2-tetramer response after gluten challenge	6 days.	FACS analysis of peripheral blood after gluten challenge.

Secondary Outcome Measures

Name	Time	Method
Mucosal responses to 3 day gluten challenge.	4 days.	Biopsy the fourth day of gluten challenge.

Trial Locations

Locations (1)

Department of Medicine, Endoscopy Unit, Rikshospitalet; 🇳🇴 Oslo, Norway