Colitis, UlcerativeIBSENIIINCT02727959
Inflammatory Bowel Disease in South Eastern Norway
An observational study of Colitis, Ulcerative and Crohn Disease, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Disease
- How many people
- 2,286 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- UC, CD, IBD
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients newly diagnosed with IBD | Not described | |
| Symptomatic non IBD-controls | Patients referred with symptoms suspicious of IBD, but who, after examination, are found not to have the diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
Secondary outcomes (6)
Change in IBD diagnosis between baseline and one year follow-up
Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria
Measured: 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
Measured: 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
Measured: 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
Measured: 5 year (+/-3 months)
IBD related bowel surgery
Bowel surgery for any IBD related condition
Measured: 1 year (+/-3 months)
IBD related bowel surgery
Bowel surgery for any IBD related condition
Measured: 5 year (+/-3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Oslo Metropolitan University, Takeda, Ferring Pharmaceuticals
- Responsible party
- Principal investigator, Marte Lie Høivik, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727959
- Sponsor's protocol ID
- 581912
- Acronym
- IBSENIII
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2016
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mathisen CB, Nystrom N, Bazov I, Oyas O, Zucknick M, Andersen S, Olbjorn C, Perminow G, Kristensen VA, Opheim R, D'Amato M, Carlson M, Hedin CRH, Keita AV, Lindqvist CM, Magnusson MK, Salihovic S, Soderholm JD, Ohman L, Kruse R, Repsilber D, Halfvarson J, Hoivik ML. A novel diagnostic serum protein signature for pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1208-1217. doi: 10.1002/jpn3.70379. Epub 2026 Feb 16.
PubMed 41693471Andersen 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.
PubMed 40888250
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Bowel Disease in South Eastern Norway (IBSEN III). Clinical Epidemiology, Diagnostic and Prognostic Factors in Inflammatory Bowel Disease.
- ClinicalTrials.gov ID
- NCT02727959
- Acronym / sponsor ID
- IBSENIII / 581912
- Keywords
- UC, CD, IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,286 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Oslo Metropolitan University, Takeda, Ferring Pharmaceuticals
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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.
- History of abdominal pain, weight loss and/or diarrhea for more than three months.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Change in IBD diagnosis between baseline and one year follow-up
Time frame: 1 year (+/-3 months)
Change in IBD diagnosis between one year and five year follow-up
Time frame: 5 year (+/-3 months)
Change in disease classification (montreal Classification) between baseline and one year follow-up.
Time frame: 1 year (+/-3 months)
Change in disease classification (montreal Classification) between one and five year follow-up
Time frame: 5 year (+/-3 months)
IBD related bowel surgery
Time frame: 1 year (+/-3 months)
IBD related bowel surgery
Time frame: 5 year (+/-3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 41693471Mathisen CB, Nystrom N, Bazov I, Oyas O, Zucknick M, Andersen S, Olbjorn C, Perminow G, Kristensen VA, Opheim R, D'Amato M, Carlson M, Hedin CRH, Keita AV, Lindqvist CM, Magnusson MK, Salihovic S, Soderholm JD, Ohman L, Kruse R, Repsilber D, Halfvarson J, Hoivik ML. A novel diagnostic serum protein signature for pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1208-1217. doi: 10.1002/jpn3.70379. Epub 2026 Feb 16.
- Derived from this study: PubMed 40888250Andersen 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.
- IBSEN III webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, Ulcerative and Crohn Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence for ulcerative colitis, Crohn's disease or indeterminate colitis based on specific clinical, endoscopic, histological and radiological criteria (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.