A Blood Based Diagnostic Test for Coeliac Disease

University of Oslo (UIO)

Status

Completed

Conditions

Coeliac Disease

Non Coeliac Gluten Sensitivity

Study type

Observational

Funder types

Other

Identifiers

NCT02442219

2011/2472

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

HLA DQ2.5 positives in primary blinded study (other HLA-types ie DQ8 and DQ2.2 in later unblinded study)
In gluten free group: Diagnosis must be confirmed by duodenal biopsy done after sufficient time on gluten containing diet and participant must have followed a glutenfree diet since.

Exclusion criteria