Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05086458
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2021-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gut microbiota at 42 days between no intervention group and experimental group.', 'timeFrame': '42 days', 'description': 'Study the microbiota change of stool samples at 42 days between no intervention group and experimental group.'}, {'measure': 'Change in gut microbiota at 14 days between no intervention and experimental group.', 'timeFrame': '14 days', 'description': 'Study the microbiota change of stool samples 14 days between no intervention group and experimental group.'}], 'secondaryOutcomes': [{'measure': 'Change in gut microbiota at birth between no intervention and experimental group.', 'timeFrame': 'birth', 'description': 'Study the microbiota change of stool samples at birth between no intervention group and experimental group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiota', 'probiotics', 'infant', 'cesarean section'], 'conditions': ['Gut Microbiota']}, 'referencesModule': {'references': [{'pmid': '37712964', 'type': 'DERIVED', 'citation': 'Gong Y, Zhong H, Wang J, Wang X, Huang L, Zou Y, Qin H, Yang R. Effect of Probiotic Supplementation on the Gut Microbiota Composition of Infants Delivered by Cesarean Section: An Exploratory, Randomized, Open-label, Parallel-controlled Trial. Curr Microbiol. 2023 Sep 15;80(11):341. doi: 10.1007/s00284-023-03444-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.', 'detailedDescription': 'This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants born by cesarean section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates born by caesarean section\n\nExclusion Criteria:\n\n* Gestational weeks \\<37 Birth weight \\<2500g or ≥4000g History of asphyxia anoxia at birth With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases With infectious diseases'}, 'identificationModule': {'nctId': 'NCT05086458', 'briefTitle': 'Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants: an Open-label Single-center Randomized Parallel Controlled Study', 'orgStudyIdInfo': {'id': 'SHSYEK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'the patients in this arm will not receive probiotics.'}, {'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement', 'description': 'the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks.', 'interventionNames': ['Dietary Supplement: probiotics']}], 'interventions': [{'name': 'probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis', 'armGroupLabels': ['Dietary Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20072', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Yang, MD', 'role': 'CONTACT', 'email': 'yangrongtongji@163.com', 'phone': '13321917107'}, {'name': 'Huanlong Qin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rong Yang', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Rong Yang, MD', 'role': 'CONTACT', 'email': 'yangrongtongji@163.com', 'phone': '13321917107'}, {'name': 'Hui Zhong', 'role': 'CONTACT', 'email': 'zhonghuiunique@126.com', 'phone': '13701806709'}], 'overallOfficials': [{'name': 'Huanlong Qin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Huanlong Qin', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}