Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-30 @ 4:03 AM
Study NCT ID:
NCT04593368
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': '7 days after FMT', 'description': 'frequency of decolonization'}, {'measure': 'frequency of SAEs', 'timeFrame': '1 month after FMT', 'description': 'frequency of SAEs due to FMT'}], 'secondaryOutcomes': [{'measure': 'Decolonization', 'timeFrame': '30 days after FMT', 'description': 'frequency of decolonization'}, {'measure': 'acute gut GVHD CI', 'timeFrame': '100 days after HSCT', 'description': 'CI of gut GVHD'}, {'measure': 'Toxicity frequency', 'timeFrame': '7 days after FMT', 'description': 'frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0)'}, {'measure': 'Bacteremia', 'timeFrame': '100 days after FMT', 'description': 'frequency of bacteremia'}, {'measure': 'Translocation', 'timeFrame': '1 year', 'description': 'frequency of translocation of pathogens from gut'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'hematopoetic stem-cell transplantation', 'FMT', 'microbiome'], 'conditions': ['Antibiotic Resistant Strain']}, 'descriptionModule': {'briefSummary': 'a clinical trial designed to prospectively assess the safety and effectiveness of fecal microbiota transplantation (FMT) prior to allogeneic hematopoietic stem-cell translation (HSCT) in patients contaminated with antibiotic-resistant pathogens (ARP)', 'detailedDescription': "The investigator's question is whether FMT decontaminates ARP and as a result, decreases the risk of severe infection which leads to transplant-related morbidity and mortality after HSCT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Recipients\n\nInclusion Criteria:\n\n1. detection by microbiology culture in any localization species of:\n\n * Pseudomonas aeruginosa\n * Clostridium difficile\n * Vancomycin-resistant Enterococcus\n * Streptococcus viridans\n * ESBL Enterobacteriaceae, including Escherichia coli and Klebsiella pneumoniae\n * Stenotrophomonas maltophilia\n * Acinetobacter\n * Methicillin-resistant Staphylococcus aureus\n2. Indications for allo-HSCT\n\nExclusion Criteria:\n\n1. indications for therapy with antibiotics for the next 7 days after FMT\n2. Nonstable condition during 1 week before FMT\n3. Therapy with antibiotics less than 48 hours before FMT\n4. Age less than 3 years\n5. Neutrophils count \\< 0,5 K/mcL at FMT day and\\\\or predicted decrease during 2 days after Donors (healthy volunteers)\n\nInclusion Criteria:\n\n1. Age 3-50 years old\n2. Donor choosing order in the absence of contraindications:\n\n1\\) HLA-match/mismatch HSCT family donor; 2) Closest family relative with whom the recipient lives; 3) Unrelated healthy volunteer from the FRCC PCM bank of frozen transplants\n\nExclusion Criteria:\n\n1. Presens of:\n\n * ESBL Esherihia coli\n * Klebsiella pneumoniae\n * Pseudomonas aeruginosa\n * Clostridium difficile\n * MRSA\n * VRE\n * Streptococcus viridans\n * ESBL Enterobacteriaceae\n * Stenotrophomonas maltophilia\n * Acinetobacter in feces by microbiology culture assay\n2. Therapy with antibiotics less than 3 months before donation\n3. Any infection disease revealed during the screening\n4. Latent period of infection disease according to the questionnaire\n5. Gut disease\n6. Longitudinal treatment with drugs\n7. Any diet for 3 months before donation.\n8. Obesity (BMI ≥ 30).'}, 'identificationModule': {'nctId': 'NCT04593368', 'acronym': 'FMT-HSCT', 'briefTitle': 'Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)', 'organization': {'class': 'OTHER', 'fullName': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology'}, 'officialTitle': 'Prospective Non-randomized Phase II Clinical Trial of Safety and Efficacy of Fecal Microbiome Transplantation for Pediatric Patients 3-18 Years Old With Confirmed Colonization With Antibiotic-resistant Bacterias and Indication for Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'NCPHOI-2019-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT', 'interventionNames': ['Other: FMT']}], 'interventions': [{'name': 'FMT', 'type': 'OTHER', 'description': 'oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight', 'armGroupLabels': ['FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '117198', 'city': 'Moscow', 'country': 'Russia', 'contacts': [{'name': 'Zhanna Shekhovtsova', 'role': 'CONTACT', 'email': 'zhanna.shekhovtsova@fccho-moscow.ru', 'phone': '84956647078', 'phoneExt': '5553'}], 'facility': 'Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'contacts': [{'name': 'Elena Zhgun', 'role': 'CONTACT', 'email': 'al.androva@gmail.com', 'phone': '84992464438'}], 'facility': 'Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'contacts': [{'name': 'Oleg GOLOSHCHAPOV', 'role': 'CONTACT', 'email': 'Golocht@yandex.ru'}], 'facility': 'RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Zhanna Shekhovtsova', 'role': 'CONTACT', 'email': 'zhanna.shekhovtsova@fccho-moscow.ru', 'phone': '84956647078', 'phoneExt': '5553'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}