HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

Celiac Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100099
• Other study ID #: 2007068
• Secondary ID: 2007068 2009021
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 6, 2010
• Last updated: September 18, 2012
• Start date: September 2006
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ministry of Health and Care Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Celiac Disease
• Gluten

Intervention

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.

Locations

Country	Name	City	State
Norway	Department of Medicine, Endoscopy Unit, Rikshospitalet	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HLA-DQ2-tetramer response after gluten challenge	FACS analysis of peripheral blood after gluten challenge.	6 days.	No
Secondary	Mucosal responses to 3 day gluten challenge.	Biopsy the fourth day of gluten challenge.	4 days.	No