Oslo University Hospital
Oslo, 0871, Norway
NCT Number: NCT02727959
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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Notify MeUp to 100 year
All sexes
Observational
Oslo, 0871, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: At baseline
Diagnosis according to the Lennard Jones Criteria for the diagnosis of inflammatory bowel disease
Time frame: 1 year (+/-3 months)
Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria
Time frame: 5 year (+/-3 months)
Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria
Time frame: 1 year (+/-3 months)
Change in disease extension and severity as defined in the Montreal classification system for IBD
Time frame: 5 year (+/-3 months)
Change in disease extension and severity as defined in the Montreal classification system for IBD
Time frame: 1 year (+/-3 months)
Bowel surgery for any IBD related condition
Time frame: 5 year (+/-3 months)
Bowel surgery for any IBD related condition
Oslo University Hospital
Other
Inflammatory Bowel Disease in South Eastern Norway (IBSEN III). Clinical Epidemiology, Diagnostic and Prognostic Factors in Inflammatory Bowel Disease.
Acronym: IBSENIII
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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