HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

September 30, 2012

Conditions
Celiac DiseaseGluten
Interventions
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.

Trial Locations (1)

0027

Department of Medicine, Endoscopy Unit, Rikshospitalet, Oslo

All Listed Sponsors
collaborator

South-Eastern Norway Regional Health Authority

OTHER

collaborator

University of Oslo

OTHER

lead

Oslo University Hospital

OTHER

NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease | Biotech Hunter | Biotech Hunter