Inflammatory Bowel Disease in South Eastern Norway

NCT02727959 | Completed

• 1 other identifier: 581912
• Study Type: observational
• Target: 2,286
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Disease

Keywords

UC; CD; IBD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  1 year (+/-3 months)

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

  5 year (+/-3 months)

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

  1 year (+/-3 months)

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

  5 year (+/-3 months)

• IBD related bowel surgery

  1 year (+/-3 months)

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Oslo Metropolitan University: collaborator
• Takeda: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0871, Norway

Location

Related Publications (1)

• 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.

  PMID: 40888250 DERIVED

Related Links

• IBSEN III webpage

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Postdoc PhD

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: April 5, 2016
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

NO (1)