Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 3:25 PM
Study NCT ID:
NCT01896635
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2013-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faecal Microbiota Transplantation in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2013-07-06', 'studyFirstSubmitQcDate': '2013-07-06', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical remission as measured by Mayo subscores', 'timeFrame': '8 weeks'}, {'measure': 'Clinical response as measured by Mayo subscores', 'timeFrame': '8 weeks'}, {'measure': 'Endoscopic healing as measured by UCEIS', 'timeFrame': '8 weeks'}, {'measure': 'Treatment failure rate as defined by Mayo subscores', 'timeFrame': '8 weeks'}, {'measure': 'Quality of life as measured by IBDQ', 'timeFrame': '8 weeks'}, {'measure': 'Safety and tolerability as measured by adverse event data', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Inflammatory Bowel Disease', 'Fecal Transplantation', 'Fecal Microbiota Transplantation'], 'conditions': ['Ulcerative Colitis', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '30529583', 'type': 'DERIVED', 'citation': 'Paramsothy S, Nielsen S, Kamm MA, Deshpande NP, Faith JJ, Clemente JC, Paramsothy R, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Lin E, Borody TJ, Wilkins MR, Colombel JF, Mitchell HM, Kaakoush NO. Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis. Gastroenterology. 2019 Apr;156(5):1440-1454.e2. doi: 10.1053/j.gastro.2018.12.001. Epub 2018 Dec 6.'}, {'pmid': '28214091', 'type': 'DERIVED', 'citation': 'Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.'}, {'pmid': '26478682', 'type': 'DERIVED', 'citation': 'Paramsothy S, Walsh AJ, Borody T, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush NO, Kamm MA. Gastroenterologist perceptions of faecal microbiota transplantation. World J Gastroenterol. 2015 Oct 14;21(38):10907-14. doi: 10.3748/wjg.v21.i38.10907.'}, {'pmid': '26070003', 'type': 'DERIVED', 'citation': 'Paramsothy S, Borody TJ, Lin E, Finlayson S, Walsh AJ, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush N, Kamm MA. Donor Recruitment for Fecal Microbiota Transplantation. Inflamm Bowel Dis. 2015 Jul;21(7):1600-6. doi: 10.1097/MIB.0000000000000405.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial', 'detailedDescription': 'This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ulcerative colitis \\>3 months duration\n* Active mild-moderate ulcerative colitis (Mayo 4-10)\n* Ulcerative colitis of any extent except isolated proctitis \\< 5cm\n* Live within driving distance of clinical site (to attend multiple study visits)\n\nExclusion Criteria:\n\n* Pregnancy\n* Active gastrointestinal infection\n* Other gastrointestinal disease / comorbidities\n* Prior colonic surgery\n* Recent antibiotic or probiotic use\n* Prednisone \\> 20mg\n* Monoclonal antibody immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT01896635', 'acronym': 'FOCUS', 'briefTitle': 'Faecal Microbiota Transplantation in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety', 'orgStudyIdInfo': {'id': 'FOCUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FMT infusions', 'description': 'FMT infusions constituted from stool provided by healthy, screened donors', 'interventionNames': ['Biological: FMT infusions']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Placebo infusions', 'interventionNames': ['Other: Placebo infusion']}], 'interventions': [{'name': 'FMT infusions', 'type': 'BIOLOGICAL', 'description': 'Active FMT derived from healthy anonymous pre-screened donors', 'armGroupLabels': ['FMT infusions']}, {'name': 'Placebo infusion', 'type': 'OTHER', 'description': 'Placebo infusion not containing any donor microbial material', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2200', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Bankstown-Lidcombe Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4560', 'city': 'Nambour', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nambour General Hospital', 'geoPoint': {'lat': -26.62613, 'lon': 152.95941}}], 'overallOfficials': [{'name': 'Hazel Mitchell, BSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New South Wales'}, {'name': 'Alissa Walsh, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital, Sydney"}, {'name': 'Johan van den Bogaerde, MBChB PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nambour General Hospital, Queensland'}, {'name': 'Douglas Samuel, MBBS MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bankstown-Lidcombe Hospital, Sydney'}, {'name': 'Nadeem O Kaakoush, BSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New South Wales'}, {'name': 'Michael Kamm, MBBS MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist / PhD candidate', 'investigatorFullName': 'Dr. Sudarshan Paramsothy', 'investigatorAffiliation': 'The University of New South Wales'}}}}