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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel diseases (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and prognostic tools.
In chronic inflammation diseases there is an excessive turnover of the extracellular tissue. Tissue is broken down to small fragments and released into the circulation. Changes in the amount of these fragments in the blood may provide information on the damage and quality of the affected tissue and may therefore act as objective measure of disease burden and severity - a so called biomarker.
The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The patients are followed for up to 1 year. Changes in biomarker are correlated to standard markers of inflammation during active disease and remission.
Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Crohns disease | Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index > 4. | ||
| Crohns disease in remission | Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4. | ||
| Active ulcerative colitis | Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index > 3. | ||
| Ulcerative colitis in remission | Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index ≤ 3. | ||
| Irritable bowel syndrome | Verified irritable bowel syndrome according to standard criteria. | ||
| Healthy controls | No known chronic diseases which needs continuously medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5) | The biomarkers are evaluated in relation to type of disease and disease activity. | Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional |
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Inclusion Criteria:
Exclusion Criteria:
Common to all participants:
Healthy control:
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IBD and IBS patients at The Department of Medical Gastroenterology, Odense University Hospital will be asked to participate when they contact the department due to progression in disease activity or at their regular consultations in the out-patient clinic.
Healthy controls will be recruited by advertising in local news paper and advertising in public places.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |