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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Upto 20 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Knut EA Ludin, PhD, MD | University of Oslo. Oslo University Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University hospital | Oslo | 0372 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29146521 | Derived | Sarna VK, Lundin KEA, Morkrid L, Qiao SW, Sollid LM, Christophersen A. HLA-DQ-Gluten Tetramer Blood Test Accurately Identifies Patients With and Without Celiac Disease in Absence of Gluten Consumption. Gastroenterology. 2018 Mar;154(4):886-896.e6. doi: 10.1053/j.gastro.2017.11.006. Epub 2017 Nov 14. |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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).
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |