An observational study in Colitis, Ulcerative, Crohn Disease and Inflammatory Bowel Disease, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-05.
Sponsored by Oslo University Hospital · Observational
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.
1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.
This study's enrollment of 2,286 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Patients referred with symptoms suspicious of IBD, but who, after examination, are found not to have the diagnosis.
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
Time frame: At baseline
Change in IBD diagnosis between baseline and one year follow-up
Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 year (+/-3 months)
IBD related bowel surgery
Bowel surgery for any IBD related condition
Time frame: 1 year (+/-3 months)
IBD related bowel surgery
Bowel surgery for any IBD related condition
Time frame: 5 year (+/-3 months)
Plan to share: Undecided
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital