Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-04 @ 11:01 PM
Study NCT ID:
NCT01961492
Status:
WITHDRAWN
Last Update Posted:
2018-10-17
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation in Patients With 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': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Problems in recruiting', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activity of ulcerative colitis', 'timeFrame': 'Within 1 year after the intervention', 'description': 'Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Colonic inflammation', 'timeFrame': 'Within 1 year after the intervention', 'description': 'Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.'}, {'measure': 'Colonic inflammation', 'timeFrame': 'Within 1 year after the intervention', 'description': 'Endoscopic Mayo score at 3 and 12 months after the intervention'}, {'measure': 'Adverse events', 'timeFrame': 'Within 1 year after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed\n\nExclusion Criteria:\n\n* severe ulcerative colitis (PUCAI \\> 65)'}, 'identificationModule': {'nctId': 'NCT01961492', 'briefTitle': 'Fecal Microbiota Transplantation in Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis', 'orgStudyIdInfo': {'id': '15881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fecal microbiota transplantation', 'description': 'A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment', 'interventionNames': ['Other: Fecal microbiota transplantation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard medical treatment', 'description': 'Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.'}], 'interventions': [{'name': 'Fecal microbiota transplantation', 'type': 'OTHER', 'description': 'A single fecal microbiota transplantation through colonoscope', 'armGroupLabels': ['Fecal microbiota transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Marko Kalliomäki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Marko Kalliomäki', 'investigatorAffiliation': 'Turku University Hospital'}}}}