A Blood Based Diagnostic Test for Coeliac Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2025-07-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Coeliac Disease Non Coeliac Gluten Sensitivity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Coeliac

Persons with coeliac disease on a gluten free diet where diagnosis is confirmed by duodenal biopsy.

No interventions assigned to this group

Non coeliac gluten sensitive

Persons on a gluten free diet where coeliac disease is excluded by duodenal biopsy.

No interventions assigned to this group

Healthy control group

Persons on a gluten containing diet without known coeliac disease.

No interventions assigned to this group

Eligibility Criteria

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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.