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A Blood Based Diagnostic Test for Coeliac Disease

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ClinicalTrials.gov Identifier: NCT02442219
Recruitment Status : Unknown
Verified July 2020 by Knut E. A. Lundin, Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 13, 2015
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Knut E. A. Lundin, Oslo University Hospital

Study Description
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Brief 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.

Condition or disease
Coeliac Disease Non Coeliac Gluten Sensitivity

Study Design
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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Blood Based Diagnostic Test for Coeliac Disease
Actual Study Start Date : February 2015
Estimated Primary Completion Date : November 27, 2021
Estimated Study Completion Date : November 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Groups and Cohorts
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Group/Cohort
Coeliac
Persons with coeliac disease on a gluten free diet where diagnosis is confirmed by duodenal biopsy.
Non coeliac gluten sensitive
Persons on a gluten free diet where coeliac disease is excluded by duodenal biopsy.
Healthy control group
Persons on a gluten containing diet without known coeliac disease.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Upto 20 months ]

Biospecimen Retention:   Samples With DNA
A tetramerbased bloodtest which will bind and identify gluten specific T-cells by the use of a flow cytometer. 50 ml blood will be needed for this test, along with characterization of other blood values (eg. Hb, leukocytes, transferrin binding, B12, biobanking etc).

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants are invited through announcement in media. Eligibility is tested through HLA-test and previous workup with confirmation / exclusion of coeliac disease by reference method (duodenal biopsy).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442219


Locations
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Norway
Oslo University hospital
Oslo, Norway, 0372
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
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Principal Investigator: Knut EA Ludin, PhD, MD University of Oslo. Oslo University Hospital.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Knut E. A. Lundin, Associate professor, phD, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02442219    
Other Study ID Numbers: 2011/2472
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Keywords provided by Knut E. A. Lundin, Oslo University Hospital:
gluten
Tetramer
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases