Inflammatory Bowel Disease in South Eastern Norway (IBSENIII)

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Disease

• Study Type: Observational
• Enrollment (Actual): 2286

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0871
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

Ulcerative colitis:

Diagnostic criteria (at least three out of four criteria present):

1. A history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes.
2. Macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon.
3. Microscopic features on biopsy compatible with UC,
4. No suspicion of CD on small bowel X-ray, ileocolonoscopy or biopsy.

Crohn's disease:

Diagnostic criteria (at least two of four criteria present):

1. History of abdominal pain, weight loss and/or diarrhea for more than three months.
2. Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning.
3. Histopathology consistent with Crohn's disease (epitheloid granuloma of Langerhans type or transmural discontinuous focal or patchy inflammation).
4. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Ferring Pharmaceuticals; Takeda; Oslo Metropolitan University

Publications and helpful links

Helpful Links

• IBSEN III webpage

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (ESTIMATE): April 5, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: IBD; CD; UC
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis, Ulcerative
• Other Study ID Numbers: 581912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED