Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-12 @ 10:06 PM
Study NCT ID:
NCT03678493
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of FMT in Patients With AML Allo HSCT in Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arashidi@umn.edu', 'phone': '(612) 273-8383', 'title': 'Armin Rashidi, MD, PhD', 'organization': 'University of Minnesota, Masonic Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 22, 'seriousNumAtRisk': 49, 'deathsNumAffected': 6, 'seriousNumAffected': 22}, {'id': 'EG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 3, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Bloodstream infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bloodstream infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'OG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '1.67'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.35', 'upperLimit': '2.65'}, {'value': '0.89', 'groupId': 'OG002', 'lowerLimit': '0.60', 'upperLimit': '1.19'}, {'value': '1.09', 'groupId': 'OG003', 'lowerLimit': '0.55', 'upperLimit': '1.64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 Months', 'description': 'Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.', 'unitOfMeasure': 'Infections', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FMT Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3192', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '.301'}, {'value': '0.1117', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.2675'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Weeks after first FMT treatment', 'description': 'Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.', 'unitOfMeasure': 'Proportion of Donor Microbiome FMT', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria."}, {'type': 'SECONDARY', 'title': 'FMT Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4767', 'groupId': 'OG000'}, {'value': '0.2626', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.2452'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Weeks after first FMT treatment', 'description': 'Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.', 'unitOfMeasure': 'Proportion of Donor Microbiome FMT', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'Placebo Comparator: Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '43'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 180 post-HCT, up to 7 months', 'description': 'Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV). Monitored each visit through safety assessment. Grade II better, Grade IV worse.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of BSI of Suspected Gut Origin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'OG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week after first FMT treatment', 'description': 'Number of BSI of suspected gut origin. Monitored each visit through safety assessment.', 'unitOfMeasure': 'Bloodstream infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Bacterial Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'OG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 Months after first FMT treatment', 'description': 'Number of Bacterial Infections. Monitored each visit through safety assessment.', 'unitOfMeasure': 'Infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Viral Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'OG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 Months after first FMT treatment', 'description': 'Number of Viral Infections. Monitored each visit through safety assessment.', 'unitOfMeasure': 'Infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Fungal Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'OG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'OG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 Months after first FMT treatment', 'description': 'Number of Fungal Infections. Monitored each visit through safety assessment.', 'unitOfMeasure': 'Infections', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AML Patients Undergoing Intensive Chemotherapy', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'FG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'FG002', 'title': 'Patients Undergoing Allo-HCT', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'FG003', 'title': 'Patients Undergoing Allo-HCT Control', 'description': 'Placebo: Oral Capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AML Patients Undergoing Intensive Chemothera', 'description': 'Fecal Microbiota Transplant (FMT): Oral Capsule'}, {'id': 'BG001', 'title': 'AML Patients Undergoing Intensive Chemotherapy Control', 'description': 'Placebo: Oral Capsule'}, {'id': 'BG002', 'title': 'Patients Undergoing Allo-HCT Patients', 'description': 'Fecal Microbiota 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'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-16', 'size': 915375, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-24T12:58', 'hasProtocol': True}, {'date': '2021-11-03', 'size': 7678658, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-24T12:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2018-09-18', 'resultsFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-22', 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections', 'timeFrame': '4 Months', 'description': 'Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.'}], 'secondaryOutcomes': [{'measure': 'FMT Engraftment', 'timeFrame': '2 Weeks after first FMT treatment', 'description': 'Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.'}, {'measure': 'FMT Engraftment', 'timeFrame': '4 Weeks after first FMT treatment', 'description': 'Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.'}, {'measure': 'Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)', 'timeFrame': 'Day 180 post-HCT, up to 7 months', 'description': 'Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV). Monitored each visit through safety assessment. Grade II better, Grade IV worse.'}, {'measure': 'Number of BSI of Suspected Gut Origin', 'timeFrame': '1 week after first FMT treatment', 'description': 'Number of BSI of suspected gut origin. Monitored each visit through safety assessment.'}, {'measure': 'Number of Bacterial Infections', 'timeFrame': '4 Months after first FMT treatment', 'description': 'Number of Bacterial Infections. Monitored each visit through safety assessment.'}, {'measure': 'Number of Viral Infections', 'timeFrame': '4 Months after first FMT treatment', 'description': 'Number of Viral Infections. Monitored each visit through safety assessment.'}, {'measure': 'Number of Fungal Infections', 'timeFrame': '4 Months after first FMT treatment', 'description': 'Number of Fungal Infections. Monitored each visit through safety assessment.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'Allo-HCT'], 'conditions': ['Acute Myeloid Leukemia', 'Allogeneic Hematopoietic Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '37235836', 'type': 'DERIVED', 'citation': 'Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Kazadi D, Halaweish H, Khan MH, Hoeschen A, Cao Q, Luo X, Kabage AJ, Lopez S, Holtan SG, Weisdorf DJ, Khoruts A, Staley C. Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML. J Clin Oncol. 2023 Dec 1;41(34):5306-5319. doi: 10.1200/JCO.22.02366. Epub 2023 May 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ageā„ 18 years\n* Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory).\n\n \\* Any intensive regimen with planned \\~4 weeks of inpatient stay\n* Cohort B: Allo-HCT patients\n\n \\* Any allogeneic transplant regimen with planned GVHD prophylaxis containing generic IV Mycophenolate Mofetil (MMF) and tacrolimus (Tac)\n* Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least six months post-FMT/placebo\n* Voluntary written consent signed before performance of any study-related procedure not part of normal medical care\n\nExclusion Criteria:\n\n* Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC \\> 1,000)\n* Patients who are currently receiving or recently received (within 28 days) other investigational agents.\n* Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy'}, 'identificationModule': {'nctId': 'NCT03678493', 'briefTitle': 'A Study of FMT in Patients With AML Allo HSCT in Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients', 'orgStudyIdInfo': {'id': '2017LS170'}, 'secondaryIdInfos': [{'id': 'MT2018-01', 'type': 'OTHER', 'domain': 'University of Minnesota Masonic Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AML Patients undergoing Intensive Chemotherapy', 'interventionNames': ['Biological: Fecal Microbiota Transplant (FMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'AML Patients undergoing Intensive Chemotherapy Control', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Patients undergoing Allo-HCT Patients', 'interventionNames': ['Biological: Fecal Microbiota Transplant (FMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients undergoing Allo-HCT Patients Control', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Fecal Microbiota Transplant (FMT)', 'type': 'BIOLOGICAL', 'otherNames': ['FMT'], 'description': 'Oral Capsule', 'armGroupLabels': ['AML Patients undergoing Intensive Chemotherapy', 'Patients undergoing Allo-HCT Patients']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral Capsule', 'armGroupLabels': ['AML Patients undergoing Intensive Chemotherapy Control', 'Patients undergoing Allo-HCT Patients Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center at University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Armin Rashidi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota, Division of Hematology, Oncology and Transplantation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}