NCT01100099

HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Celiac Disease
• Gluten

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2012-09-01
• First posted: 2010-04-08
• Last updated: 2012-09-19

Locations

1 site across 1 country: Norway