A Blood Based Diagnostic Test for Coeliac Disease
Study Purpose
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 Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02442219 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Oslo University Hospital |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Knut EA Ludin, PhD, MD |
| Principal Investigator Affiliation | University of Oslo. Oslo University Hospital. |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | Norway |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Coeliac Disease, Non Coeliac Gluten Sensitivity |
Contact a Trial Team
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