Back to resultsHLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
Primary Purpose
Celiac Disease, Gluten
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Gluten challenge.
Sponsored by
About this trial
This is an interventional diagnostic trial for Celiac Disease focused on measuring Celiac disease., Food intolerance., Gluten intolerance without celiac disease.
Eligibility Criteria
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
Sites / Locations
- Department of Medicine, Endoscopy Unit, Rikshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gluten challenge.
Arm Description
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.
Outcomes
Primary Outcome Measures
HLA-DQ2-tetramer response after gluten challenge
FACS analysis of peripheral blood after gluten challenge.
Secondary Outcome Measures
Mucosal responses to 3 day gluten challenge.
Biopsy the fourth day of gluten challenge.
Full Information
NCT ID
NCT01100099
First Posted
April 6, 2010
Last Updated
September 18, 2012
Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT01100099
Brief Title
HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, University of Oslo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Gluten
Keywords
Celiac disease., Food intolerance., Gluten intolerance without celiac disease.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gluten challenge.
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Gluten challenge.
Intervention Description
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.
Primary Outcome Measure Information:
Title
HLA-DQ2-tetramer response after gluten challenge
Description
FACS analysis of peripheral blood after gluten challenge.
Time Frame
6 days.
Secondary Outcome Measure Information:
Title
Mucosal responses to 3 day gluten challenge.
Description
Biopsy the fourth day of gluten challenge.
Time Frame
4 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Medicine, Endoscopy Unit, Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
17307878
Citation
Raki 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. doi: 10.1073/pnas.0608610104. Epub 2007 Feb 16.
Results Reference
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HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
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