A Blood Based Diagnostic Test for Coeliac Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02442219|
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : January 14, 2019
|Condition or disease|
|Coeliac Disease Non Coeliac Gluten Sensitivity|
|Study Type :||Observational|
|Estimated Enrollment :||144 participants|
|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|
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.
- 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
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
|Contact: Vikas K Sarna, MD||23073813 ext +firstname.lastname@example.org|
|Contact: Knut EA Lundin, PhD, MD||23072400 ext +email@example.com|
|Principal Investigator:||Knut EA Ludin, PhD, MD||University of Oslo. Oslo University Hospital.|