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
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Condition or disease |
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Coeliac Disease Non Coeliac Gluten Sensitivity |
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 |

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

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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 |
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

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
Norway | |
Oslo University hospital | |
Oslo, Norway, 0372 |
Principal Investigator: | Knut EA Ludin, PhD, MD | University of Oslo. Oslo University Hospital. |
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 |
gluten Tetramer |
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |