HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
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|ClinicalTrials.gov Identifier: NCT01100099|
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : September 19, 2012
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2006|
|Primary Completion Date :||December 2009|
|Study Completion Date :||September 2012|
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.
- HLA-DQ2-tetramer response after gluten challenge [ Time Frame: 6 days. ]FACS analysis of peripheral blood after gluten challenge.
- Mucosal responses to 3 day gluten challenge. [ Time Frame: 4 days. ]Biopsy the fourth day of gluten challenge.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100099
|Department of Medicine, Endoscopy Unit, Rikshospitalet|
|Oslo, Norway, 0027|