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HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

NCT ID: NCT01100099

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Celiac Disease Gluten

Keywords

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Celiac disease. Food intolerance. Gluten intolerance without celiac disease.

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gluten challenge.

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* HLA-DQ2+ celiacs and HLA-DQ2+ persons who have been on a gluten free diet for at least 4 weeks.

Exclusion Criteria

* Other severe disease
* Refusal to participate
* HLA-DQ2 negativity
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Medicine, Endoscopy Unit, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 17307878 (View on PubMed)

Other Identifiers

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2007068 2009021

Identifier Type: OTHER

Identifier Source: secondary_id

2007068

Identifier Type: -

Identifier Source: org_study_id