NCT02442219

A Blood Based Diagnostic Test for Coeliac Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Timeline

• Start date: 2015-02-01
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2015-05-13
• Last updated: 2025-07-30

Locations

1 site across 1 country: Norway