HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

This study has been completed.
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01100099
First received: April 6, 2010
Last updated: September 18, 2012
Last verified: September 2012

April 6, 2010
September 18, 2012
September 2006
December 2009   (final data collection date for primary outcome measure)
HLA-DQ2-tetramer response after gluten challenge [ Time Frame: 6 days. ] [ Designated as safety issue: No ]
FACS analysis of peripheral blood after gluten challenge.
Same as current
Complete list of historical versions of study NCT01100099 on ClinicalTrials.gov Archive Site
Mucosal responses to 3 day gluten challenge. [ Time Frame: 4 days. ] [ Designated as safety issue: No ]
Biopsy the fourth day of gluten challenge.
Same as current
Not Provided
Not Provided
 
HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Celiac Disease
  • Gluten
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.
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.
Intervention: Dietary Supplement: Gluten challenge.
Ráki M, Fallang LE, Brottveit M, Bergseng E, Quarsten H, Lundin KE, Sollid LM. Tetramer visualization of gut-homing gluten-specific T cells in the peripheral blood of celiac disease patients. Proc Natl Acad Sci U S A. 2007 Feb 20;104(8):2831-6. Epub 2007 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2012
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01100099
2007068, 2007068 2009021
No
Oslo University Hospital
Oslo University Hospital
  • South-Eastern Norway Regional Health Authority
  • University of Oslo
Not Provided
Oslo University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP