Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03477032
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FMT in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D046728', 'term': 'Colitis, Microscopic'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-26', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinical remission as defined by Crohn's disease activity index less than 150", 'timeFrame': '8 weeks', 'description': 'CDAI \\<150'}, {'measure': 'Clinical remission in Ulcerative colitis: Total MAYO score </= 2', 'timeFrame': '8 weeks', 'description': 'Total Mayo score of \\</=2, with all mayo sub-scores being 1 or less'}, {'measure': 'Clinical remission in Microscopic colitis', 'timeFrame': '8 weeks', 'description': 'Mean of \\<3 stools/day, including a mean of \\<1 watery stool/day over 1 week and if steroid dependent, the ability to cease steroids without increasing symptoms over baseline disease activity assessment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Faecal Microbiota Transplantation', 'Crohn Disease', 'Ulcerative Colitis', 'Microscopic Colitis']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational cohort study, over 52 weeks, evaluating the the use of faecal microbiota transplantation amongst patients with Inflammatory Bowel Disease and Microscopic Colitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with active inflammatory bowel disease or microscopic collitis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with inflammatory bowel disease (Crohn's disease or Ulcerative colitis) or Microscopic Colitis proven on the basis of radiology, endoscopy or histology.\n* Patients with clinically and endoscopically active, Crohn's Disease, Ulcerative Colitis or Microscopic Colitis\n* Patient must have attempted reasonable medical therapies to control their disease without sufficient response.\n* All patients have to be capable of attending appointments, as well completing surveys and diagnostic tests for the duration of study follow up\n* The patient must be able to identify a likely stool donor\n\nExclusion Criteria:\n\n* Patients with an enteropathy or colitis which cannot definitively be diagnosed as Ulcerative Colitis, Crohn's disease or Microscopic colitis\n* Patients with concurrent Clostridium difficile infection\n* Women who are pregnant or intending to become pregnant in the near future (less than 6 months).\n* Neutrophils less than 1.0 x 109/L\n* Albumin less than 20g/L\n* Active gastrointestinal infection as identified by testing\n* A patient on steroids (prednisolone, budesonide) at a dose that cannot be safely tapered to zero within 6 weeks of initial FMT, due to the risk of adrenal insufficiency\n* Short gut syndrome and/or small intestine less than 1.5m in length as measured intra-operatively\n* Perforation or active internal fistulising disease or enterocutaneous fistulae.\n* Any patient that the clinicians feel is incapable of participating in the safe use of FMT.\n* Current use of antibiotics for any condition"}, 'identificationModule': {'nctId': 'NCT03477032', 'briefTitle': 'FMT in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': "St Vincent's Hospital Melbourne"}, 'officialTitle': 'Faecal Transplantation in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': "St Vincent's Hospital"}}, 'armsInterventionsModule': {'interventions': [{'name': 'Faecal Microbiota Transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['FMT'], 'description': 'Faeces acquired from a healthy donor'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Amy Hamilton, PhD', 'role': 'CONTACT'}], 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Amy Hamilton, PhD', 'role': 'CONTACT', 'email': 'svhm.fmt.ibd@svha.org.au', 'phone': '03 9231 2211'}], 'overallOfficials': [{'name': 'Michael Kamm, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}, {'name': 'Emily Wright, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}, {'name': 'Chamara Basnayake, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}, {'name': 'Amy Hamilton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Vincent's Hospital Melbourne", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael Kamm', 'investigatorAffiliation': "St Vincent's Hospital Melbourne"}}}}