A Blood Based Diagnostic Test for Coeliac Disease

Coeliac Disease Clinical Trial

Official title:

A Blood Based Diagnostic Test for Coeliac Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02442219
• Other study ID #: 2011/2472
• Status: Active, not recruiting
• Start date: February 2015
• Est. completion date: November 27, 2021

Study information

• Verified date: July 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: November 27, 2021
• Est. primary completion date: November 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Drugs that influence the immune system used last three months

• Infected with Hepatitis B, C or HIV

• Pregnant

Related Conditions & MeSH terms

• Celiac Disease
• Coeliac Disease
• Non Coeliac Gluten Sensitivity

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry		Upto 20 months