Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT02801656
Status:
WITHDRAWN
Last Update Posted:
2022-04-29
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Cure of diarrhea without recurrence in intention to treat population', 'timeFrame': '56 days', 'description': 'Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.'}, {'measure': 'Adverse Events', 'timeFrame': '56 days', 'description': 'Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Cure of diarrhea without recurrence in a per protocol population', 'timeFrame': '56 days', 'description': 'Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.'}, {'measure': 'Efficacy: cure of diarrhea in intention to treat and per protocol populations', 'timeFrame': '10 days', 'description': 'Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.'}, {'measure': 'Efficacy: time to cure of diarrhea', 'timeFrame': '56 days', 'description': 'Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.'}, {'measure': 'Efficacy: Health status questionnaire', 'timeFrame': '56 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile']}, 'descriptionModule': {'briefSummary': 'Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.', 'detailedDescription': 'Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* life expectancy \\> 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization\n\nExclusion Criteria:\n\n* pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received \\>4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count \\<200, or any medical or non-medical condition considered by the investigator to preclude participation.'}, 'identificationModule': {'nctId': 'NCT02801656', 'briefTitle': 'Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Memorial University of Newfoundland'}, 'officialTitle': 'Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MUN-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal Microbiota Transplantation', 'description': 'Oral, encapsulated fecal microbiota transplantation', 'interventionNames': ['Biological: Fecal Microbiota Transplantation', 'Drug: Vancomycin Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': '125 mg po qid x 10 days', 'interventionNames': ['Drug: Vancomycin', 'Biological: Fecal Microbiota Transplantation Placebo']}], 'interventions': [{'name': 'Fecal Microbiota Transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['Stool Transplant'], 'description': 'Oral, encapsulated FMT', 'armGroupLabels': ['Fecal Microbiota Transplantation']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': 'Vancomycin po 125 mg qid x 10 days', 'armGroupLabels': ['Vancomycin']}, {'name': 'Fecal Microbiota Transplantation Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['Stool Transplant Placebo'], 'description': 'Matching placebo to FMT', 'armGroupLabels': ['Vancomycin']}, {'name': 'Vancomycin Placebo', 'type': 'DRUG', 'otherNames': ['Vancocin Placebo'], 'description': 'Matching placebo to Vancomycin', 'armGroupLabels': ['Fecal Microbiota Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Health Sciences Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}], 'overallOfficials': [{'name': 'Peter Daley, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After analysis is completed, data will be released'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Peter Daley', 'investigatorAffiliation': 'Memorial University of Newfoundland'}}}}