Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-31 @ 7:22 PM
Study NCT ID:
NCT01193894
Status:
COMPLETED
Last Update Posted:
2013-12-17
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on Profermin and Fresubin in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574856', 'term': 'profermin'}, {'id': 'C048418', 'term': 'Fresubin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-09-01', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development in Simple Clinical Colitis Activity Index (SCCAI) score', 'timeFrame': '8 and 16 weeks', 'description': 'Clinical significant difference (\\>1.5) in course of SCCAI score between the two intervention groups'}], 'secondaryOutcomes': [{'measure': 'Reduction in SCCAI score', 'timeFrame': '8 and 16 weeks', 'description': 'Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5'}, {'measure': 'Clinical remission', 'timeFrame': '8 and 16 weeks', 'description': 'Proportion of patients in clinical remission (SCCAI=\\<2.5)'}, {'measure': 'Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IBD', 'UC', 'Profermin', 'Fresubin', 'Probiotics', 'Dietetic'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active ulcerative colitis (SCCAI =\\>5 and \\<=11)\n* Access to Internet\n\nExclusion Criteria:\n\n* Stoma or intestinal resections\n* Recent changes in UC medication\n* Treatment with antibiotics\n* Diabetes\n* Celiac disease\n* Lactose malabsorption'}, 'identificationModule': {'nctId': 'NCT01193894', 'acronym': 'CUPE2', 'briefTitle': 'Trial on Profermin and Fresubin in Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordisk Rebalance A/S'}, 'officialTitle': 'A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'CUPE2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Profermin', 'interventionNames': ['Other: Profermin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fresubin', 'interventionNames': ['Other: Fresubin']}], 'interventions': [{'name': 'Profermin', 'type': 'OTHER', 'description': 'Medical Food (food for special medical purposes)', 'armGroupLabels': ['Profermin']}, {'name': 'Fresubin', 'type': 'OTHER', 'description': 'Medical food (food for special medical purposes)', 'armGroupLabels': ['Fresubin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3450', 'city': 'Allerød Municipality', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Noreba', 'geoPoint': {'lat': 55.87035, 'lon': 12.35737}}], 'overallOfficials': [{'name': 'Hans Israelsen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nordisk Rebalance A/S'}, {'name': 'Aleksander Krag, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Flemming Bendtsen, MD, DMSci', 'role': 'STUDY_CHAIR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordisk Rebalance A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hvidovre University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}