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Completed

NCT Number: NCT01100099

HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Food Intolerance Gastrointestinal Diseases Gluten Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Medicine, Endoscopy Unit, Rikshospitalet

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten challenge.

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.

Primary outcomes

  1. HLA-DQ2-tetramer response after gluten challenge

    Time frame: 6 days.

    FACS analysis of peripheral blood after gluten challenge.

Secondary outcomes

  1. Mucosal responses to 3 day gluten challenge.

    Time frame: 4 days.

    Biopsy the fourth day of gluten challenge.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority
  • University of Oslo

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2012
First posted
Apr 8, 2010
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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