HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

NCT01100099 | Completed Phase 2

• 2 other identifiers: 20070682007068 2009021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Gluten

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HLA-DQ2-tetramer response after gluten challenge

  FACS analysis of peripheral blood after gluten challenge.

  6 days.

Secondary Outcomes (1)

• Mucosal responses to 3 day gluten challenge.

  4 days.

Study Arms (1)

Gluten challenge.

EXPERIMENTAL

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.

Dietary Supplement: Gluten challenge.

Interventions

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.

Gluten challenge.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other severe disease
• Refusal to participate
• HLA-DQ2 negativity

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• University of Oslo: collaborator

Study Sites (1)

Department of Medicine, Endoscopy Unit, Rikshospitalet

Oslo, 0027, Norway

Location

Related Publications (1)

• 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.

  PMID: 17307878 BACKGROUND

MeSH Terms

Conditions

Celiac Disease; Food Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2012
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

NO (1)