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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Oslo Metropolitan University | OTHER |
| Takeda | INDUSTRY |
| Ferring Pharmaceuticals |
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The IBSEN III study will investigate the incidence of inflammatory bowel disease in South Eastern Norway and describe the clinical course of the disease. The investigators will map newly diagnosed and treatment naive IBD patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) as a basis to improve targeted and individualized treatment and care. The investigators will include incident IBD patients at all local- and university hospitals in the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The investigators will use standardized and validated registration methods allowing comparability with previous national and international IBD cohorts, link data to national health registries and collect blood, feces and biopsies for bio banking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients newly diagnosed with IBD | |||
| Symptomatic non IBD-controls | Patients referred with symptoms suspicious of IBD, but who, after examination, are found not to have the diagnosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evidence for ulcerative colitis, Crohn's disease or indeterminate colitis based on specific clinical, endoscopic, histological and radiological criteria | Diagnosis according to the Lennard Jones Criteria for the diagnosis of inflammatory bowel disease | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IBD diagnosis between baseline and one year follow-up | Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria | 1 year (+/-3 months) |
| Change in IBD diagnosis between one year and five year follow-up |
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Inclusion Criteria:
Ulcerative colitis:
Diagnostic criteria (at least three out of four criteria present):
Crohn's disease:
Diagnostic criteria (at least two of four criteria present):
Inflammatory bowel disease, type unclassified (IBDU) :
Patients with evidence on clinical and endoscopic grounds for chronic inflammatory bowel disease affecting the colon, without small bowel involvement, and no definitive histological or other evidence to favor either CD or UC.
Pediatric patients:
Will be diagnosed according to the Porto-criteria and defined as:
Pediatric onset IBD ≤ 16 years Early Onset IBD (EOIBD) < 10 years Very Early Onset IBD (VEOIBD) < 6 years Infantile (and toddler) IBD < 2 years Neonatal IBD < 28 days
Exclusion criteria:
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Adult and pediatric patients untreated and newly diagnosed with inflammatory bowel disease i.e ulcerative colitis or Crohns disease as well as non-IBD Controls.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0871 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41693471 | Derived | Mathisen CB, Nystrom N, Bazov I, Oyas O, Zucknick M, Andersen S, Olbjorn C, Perminow G, Kristensen VA, Opheim R, D'Amato M, Carlson M, Hedin CRH, Keita AV, Lindqvist CM, Magnusson MK, Salihovic S, Soderholm JD, Ohman L, Kruse R, Repsilber D, Halfvarson J, Hoivik ML. A novel diagnostic serum protein signature for pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1208-1217. doi: 10.1002/jpn3.70379. Epub 2026 Feb 16. | |
| 40888250 |
| Label | URL |
|---|---|
| IBSEN III webpage | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| INDUSTRY |
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Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria |
| 5 year (+/-3 months) |
| Change in disease classification (montreal Classification) between baseline and one year follow-up. | Change in disease extension and severity as defined in the Montreal classification system for IBD | 1 year (+/-3 months) |
| Change in disease classification (montreal Classification) between one and five year follow-up | Change in disease extension and severity as defined in the Montreal classification system for IBD | 5 year (+/-3 months) |
| IBD related bowel surgery | Bowel surgery for any IBD related condition | 1 year (+/-3 months) |
| IBD related bowel surgery | Bowel surgery for any IBD related condition | 5 year (+/-3 months) |
| Derived |
| Andersen S, Bernklev T, Stordal K, Hagen MC, Kristensen VA, Opheim R, Olbjorn C, Rove J, Lovlund EE, Holm HK, Aballi B, Hoivik ML, Perminow G. Specific phenotypes may drive an increased incidence of pediatric inflammatory bowel disease in South-Eastern Norway. J Pediatr Gastroenterol Nutr. 2025 Nov;81(5):1227-1236. doi: 10.1002/jpn3.70148. Epub 2025 Sep 1. |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |