Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-02 @ 4:41 PM
Study NCT ID:
NCT02727959
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2016-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Bowel Disease in South Eastern Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2286}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evidence for ulcerative colitis, Crohn's disease or indeterminate colitis based on specific clinical, endoscopic, histological and radiological criteria", 'timeFrame': 'At baseline', 'description': 'Diagnosis according to the Lennard Jones Criteria for the diagnosis of inflammatory bowel disease'}], 'secondaryOutcomes': [{'measure': 'Change in IBD diagnosis between baseline and one year follow-up', 'timeFrame': '1 year (+/-3 months)', 'description': 'Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria'}, {'measure': 'Change in IBD diagnosis between one year and five year follow-up', 'timeFrame': '5 year (+/-3 months)', 'description': 'Change in diagnosis based on specified clinical, endoscopic, histological and radiological criteria'}, {'measure': 'Change in disease classification (montreal Classification) between baseline and one year follow-up.', 'timeFrame': '1 year (+/-3 months)', 'description': 'Change in disease extension and severity as defined in the Montreal classification system for IBD'}, {'measure': 'Change in disease classification (montreal Classification) between one and five year follow-up', 'timeFrame': '5 year (+/-3 months)', 'description': 'Change in disease extension and severity as defined in the Montreal classification system for IBD'}, {'measure': 'IBD related bowel surgery', 'timeFrame': '1 year (+/-3 months)', 'description': 'Bowel surgery for any IBD related condition'}, {'measure': 'IBD related bowel surgery', 'timeFrame': '5 year (+/-3 months)', 'description': 'Bowel surgery for any IBD related condition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UC', 'CD', 'IBD'], 'conditions': ['Colitis, Ulcerative', 'Crohn Disease', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '40888250', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.med.uio.no/klinmed/english/research/projects/ibsen-inflammatory-bowel-disease/', 'label': 'IBSEN III webpage'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nUlcerative colitis:\n\nDiagnostic criteria (at least three out of four criteria present):\n\n1. A history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes.\n2. Macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon.\n3. Microscopic features on biopsy compatible with UC,\n4. No suspicion of CD on small bowel X-ray, ileocolonoscopy or biopsy.\n\nCrohn's disease:\n\nDiagnostic criteria (at least two of four criteria present):\n\n1. History of abdominal pain, weight loss and/or diarrhea for more than three months.\n2. Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning.\n3. Histopathology consistent with Crohn's disease (epitheloid granuloma of Langerhans type or transmural discontinuous focal or patchy inflammation).\n4. Fistula and/or abscess in relation to affected bowel segments.\n\nInflammatory bowel disease, type unclassified (IBDU) :\n\nPatients 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.\n\nPediatric patients:\n\nWill be diagnosed according to the Porto-criteria and defined as:\n\nPediatric 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\n\nExclusion criteria:\n\n* 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.\n* Refusal or not able to give informed consent"}, 'identificationModule': {'nctId': 'NCT02727959', 'acronym': 'IBSENIII', 'briefTitle': 'Inflammatory Bowel Disease in South Eastern Norway', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Inflammatory Bowel Disease in South Eastern Norway (IBSEN III). Clinical Epidemiology, Diagnostic and Prognostic Factors in Inflammatory Bowel Disease.', 'orgStudyIdInfo': {'id': '581912'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients newly diagnosed with IBD'}, {'label': 'Symptomatic non IBD-controls', 'description': 'Patients referred with symptoms suspicious of IBD, but who, after examination, are found not to have the diagnosis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0871', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, {'name': 'Takeda', 'class': 'INDUSTRY'}, {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Postdoc PhD', 'investigatorFullName': 'Marte Lie Høivik', 'investigatorAffiliation': 'Oslo University Hospital'}}}}