Skip to main content
OpenTrials
Completed

NCT Number: NCT02727959

Inflammatory Bowel Disease in South Eastern Norway

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0871, Norway

Who can participate

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):

  • 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

Treatment and study plan

Primary outcomes

  1. Evidence for ulcerative colitis, Crohn's disease or indeterminate colitis based on specific clinical, endoscopic, histological and radiological criteria

    Time frame: At baseline

    Diagnosis according to the Lennard Jones Criteria for the diagnosis of inflammatory bowel disease

Secondary outcomes

  1. Change in IBD diagnosis between baseline and one year follow-up

    Time frame: 1 year (+/-3 months)

    Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria

  2. Change in IBD diagnosis between one year and five year follow-up

    Time frame: 5 year (+/-3 months)

    Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria

  3. Change in disease classification (montreal Classification) between baseline and one year follow-up.

    Time frame: 1 year (+/-3 months)

    Change in disease extension and severity as defined in the Montreal classification system for IBD

  4. Change in disease classification (montreal Classification) between one and five year follow-up

    Time frame: 5 year (+/-3 months)

    Change in disease extension and severity as defined in the Montreal classification system for IBD

  5. IBD related bowel surgery

    Time frame: 1 year (+/-3 months)

    Bowel surgery for any IBD related condition

  6. IBD related bowel surgery

    Time frame: 5 year (+/-3 months)

    Bowel surgery for any IBD related condition

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Ferring Pharmaceuticals
  • Oslo Metropolitan University
  • Takeda
  • University of Oslo

Registry information

Official study title

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

Acronym: IBSENIII

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2016
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.