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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 6, 2010
Last Updated Date	September 18, 2012
Start Date ^ICMJE	September 2006
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2010)	HLA-DQ2-tetramer response after gluten challenge [ Time Frame: 6 days. ] [ Designated as safety issue: No ] FACS analysis of peripheral blood after gluten challenge.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01100099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2010)	Mucosal responses to 3 day gluten challenge. [ Time Frame: 4 days. ] [ Designated as safety issue: No ] Biopsy the fourth day of gluten challenge.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Celiac Disease Gluten
Intervention ^ICMJE	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.
Study Arm (s)	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.
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	September 2012
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01100099
Other Study ID Numbers ^ICMJE	2007068, 2007068 2009021
Has Data Monitoring Committee	No
Responsible Party	Oslo University Hospital
Study Sponsor ^ICMJE	Oslo University Hospital
Collaborators ^ICMJE	South-Eastern Norway Regional Health Authority University of Oslo
Investigators ^ICMJE	Not Provided
Information Provided By	Oslo University Hospital
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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