Inflammatory Bowel Disease in South Eastern Norway

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stavanger University Hospital Inflammatory Bowel Disease Trial

NCT01551563

IBD

RECRUITING

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

NCT02073526

Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

COMPLETED

Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases

NCT02508012

Crohn's Disease Ulcerative Colitis

COMPLETED NA

Improving the Health Care in Inflammatory Bowel Disease.

NCT02770599

Crohn Disease Colitis, Ulcerative

UNKNOWN

NORDTREAT Prospective Study on Inflammatory Bowel Disease

NCT05414578

Inflammatory Bowel Diseases (IBD) Crohn Disease (CD) Ulcerative Colitis (UC)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colitis, Ulcerative Crohn Disease Inflammatory Bowel Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients newly diagnosed with IBD

No interventions assigned to this group

Symptomatic non IBD-controls

Patients referred with symptoms suspicious of IBD, but who, after examination, are found not to have the diagnosis.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No