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A Blood Based Diagnostic Test for Coeliac Disease

NCT02442219 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-07-30

No results posted yet for this study

Summary

Persons with coeliac disease treated with a gluten free diet will be asked to give blood for a new diagnostic blood test. In this test investigators will use multimerized HLA bound to different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these cells will be present in persons with coeliac disease regardless of gluten-intake. Investigators will compare their findings with two control groups; Persons on a gluten free diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten containing diet (healthy control group). In the initial and main study investigators will look at HLA DQ2.5 individuals, which comprise \>90% of all persons with coeliac disease.

Conditions

  • Coeliac Disease
  • Non Coeliac Gluten Sensitivity

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Knut EA Ludin, PhD, MD · University of Oslo. Oslo University Hospital.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2025-07-28
Completion
2025-07-28

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442219 on ClinicalTrials.gov