Medpedia

HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease

Recruiting
09/01/2006 to 12/01/2010
100
Phase 2/Phase 3
Interventional

Conditions

  • Celiac Disease
  • Gluten

Eligibility

18 - 70
Yes
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

Purpose


Interventions

  • 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.

Outcome Measures

  • HLA-DQ2-tetramer response after gluten challenge
    6 days.
    Safety Issue: No
  • Mucosal responses to 3 day gluten challenge.
    4 days.
    Safety Issue: No

Contacts

Knut EA Lundin, MD, PHD
knut.lundin@rikshospitalet.no

Locations

  • Department of Medicine, Endoscopy Unit, Rikshospitalet
    Oslo, 0027, Norway
    Recruiting
    Knut EA Lundin, MD, PhD
    0
    knut.lundin@rikshospitalet.no

    Investigators

    • Knut EA Lundin, MD, PhD
      Principal Investigator

Sponsors

  • Rikshospitalet HF
    Lead Sponsor
  • Norway: Royal Norwegian Ministry of Health and Care Services

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