Inflammatory Bowel Disease in South Eastern Norway

Study Overview
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Brief Summary
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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.

Official Title
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Inflammatory Bowel Disease in South Eastern Norway (IBSEN III). Clinical Epidemiology, Diagnostic and Prognostic Factors in Inflammatory Bowel Disease.

Conditions
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Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ulcerative colitis: Diagnostic criteria (at least three out of four criteria present): A history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes. Macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon. Microscopic features on biopsy compatible with UC, No suspicion of CD on small bowel X-ray, ileocolonoscopy or biopsy. Crohn's disease: Diagnostic criteria (at least two of four criteria present): History of abdominal pain, weight loss and/or diarrhea for more than three months. Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning. Histopathology consistent with Crohn's disease (epitheloid granuloma of Langerhans type or transmural discontinuous focal or patchy inflammation). Fistula and/or abscess in relation to affected bowel segments. 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: Other causes of acute or chronic bowel inflammation must be excluded, i.e. infectious colitis, radiation colitis, diversion colitis, solitary rectal ulcer syndrome, graft versus host disease, diverticular colitis, medication associated colitis, ischemic colitis, microscopic colitis, enema associated colitis. Refusal or not able to give informed consent

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients newly diagnosed with IBD<br> | |
| Symptomatic non IBD-controls<br>Patients referred with symptoms suspicious of IBD, but who, after examination, are found not to have the diagnosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UC, CD, IBD