Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 8:08 PM
Study NCT ID:
NCT03942159
Status:
UNKNOWN
Last Update Posted:
2020-04-07
First Post:
2019-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modification of the Human Colon and Oral Microbiome by Allogenic HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'colon and oral swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'beta-index dynamics', 'timeFrame': '7 days before HSCT', 'description': 'biodiversity (beta-index) dynamics between time points before and after HSCT'}, {'measure': 'beta-index dynamics', 'timeFrame': '7 days after HSCT', 'description': 'biodiversity (beta-index) dynamics between time points before and after HSCT'}, {'measure': 'beta-index dynamics', 'timeFrame': '60 days after HSCT', 'description': 'biodiversity (beta-index) dynamics between time points before and after HSCT'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with microbial domination after HSCT', 'timeFrame': '7 days after HSCT', 'description': 'evaluation of the dynamics of the microbial domination between time points before and after HSCT'}, {'measure': 'Proportion of patients with microbial domination after HSCT', 'timeFrame': '60 days after HSCT', 'description': 'evaluation of the dynamics of the microbial domination between time points before and after HSCT'}, {'measure': 'Shannon-index dynamics', 'timeFrame': '7 days before HSCT', 'description': 'biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT'}, {'measure': 'Shannon-index dynamics', 'timeFrame': '7 days after HSCT', 'description': 'biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT'}, {'measure': 'Shannon-index dynamics', 'timeFrame': '60 days after HSCT', 'description': 'biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT'}, {'measure': 'ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)', 'timeFrame': '7 days before HSCT', 'description': 'sensitivity of NGS as a method of biodiversity evaluation'}, {'measure': 'ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)', 'timeFrame': '7 days after HSCT', 'description': 'sensitivity of NGS as a method of biodiversity evaluation'}, {'measure': 'ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)', 'timeFrame': '60 days after HSCT', 'description': 'sensitivity of NGS as a method of biodiversity evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'stem cell transplantation'], 'conditions': ['Human Microbiome', 'HSCT']}, 'descriptionModule': {'briefSummary': 'Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indications to alloHSCT\n* nursing healthy donors 3-55 y.o.\n\nExclusion Criteria:\n\n* unable to give samples for the test\n* graft rejection\n* previous HSCT'}, 'identificationModule': {'nctId': 'NCT03942159', 'briefTitle': 'Modification of the Human Colon and Oral Microbiome by Allogenic HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology'}, 'officialTitle': 'Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor', 'orgStudyIdInfo': {'id': 'NCHPOI-2019-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Donors', 'description': 'HLA-matched or haploidentical nursing relative donors'}, {'label': 'Patients', 'description': 'recipients of allogeneic HSCT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '117997', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Zhanna Shekhovtsova, MD', 'role': 'CONTACT', 'email': 'zhanna.shekhovtsova@fccho-moscow.ru', 'phone': '4956647078', 'phoneExt': '7538'}, {'name': 'Michael Maschan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhanna Shekhovtsova', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Zhanna Shekhovtsova', 'role': 'CONTACT', 'email': 'zhanna.shekhovtsova@fccho-moscow.ru', 'phone': '84956647078', 'phoneExt': '7538'}], 'overallOfficials': [{'name': 'Michael Maschan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Center for Pediatric Hematology , Moscow, Russian Federation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}