Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT05738460
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2023-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-12', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intestinal flora', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.'}, {'measure': 'Secretory IgA', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.'}, {'measure': 'Calprotectin', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.'}], 'primaryOutcomes': [{'measure': 'Intestinal flora', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.'}, {'measure': 'Secretory IgA', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.'}, {'measure': 'Calprotectin', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.'}], 'secondaryOutcomes': [{'measure': 'Intestinal flora', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.'}, {'measure': 'Secretory IgA', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.'}, {'measure': 'Calprotectin', 'timeFrame': 'Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected', 'description': 'Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome,', 'maternal and offspring', 'healthy'], 'conditions': ['Healthy', 'Metabolism', 'Microbiome']}, 'descriptionModule': {'briefSummary': 'This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1\\~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.', 'detailedDescription': 'This is a case-control study. By collecting fecal samples of infants and young children in the observation group and control group at different time points (0\\~1 years old, 1\\~2 years old, 2\\~3 years old), the intestinal flora of infants and young children was detected by 16S rDNA sequencing, and fecal calprotectin (CP) and secretory IgA (SIgA) were detected by ELISA. To study the effects of exposure factors on intestinal flora and immunity in offspring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '41 Weeks', 'minimumAge': '37 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants: 37-41 weeks of age, born through vaginal delivery, 2500g\\<= birth weight \\< 4000g, 0-3 years of age; 2. The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 - 41 weeks to complete the GBS screening; 3. The guardian agrees to participate in the study voluntarily.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants:37-41 weeks of age, born through vaginal delivery, 2500g\\<= birth weight \\< 4000g,0-3 years of age;\n* The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;\n* The guardian agrees to participate in the study voluntarily.\n\nExclusion Criteria:\n\n* Infants and children with serious congenital abnormalities, infections or clinical diseases;\n* Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;\n* Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;\n* Any medical or non-medical condition that the investigator deems inappropriate to participate in.'}, 'identificationModule': {'nctId': 'NCT05738460', 'briefTitle': "Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.", 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring', 'orgStudyIdInfo': {'id': 'CMOH2102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reproductive tract GBS colonization group of mothers during pregnancy', 'description': 'Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics', 'interventionNames': ['Drug: antibiotics']}, {'label': 'No reproductive tract GBS colonization group in mothers during pregnancy', 'description': 'No reproductive tract GBS colonization group in mothers during pregnancy'}], 'interventions': [{'name': 'antibiotics', 'type': 'DRUG', 'otherNames': ['antibiotic'], 'description': 'Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics', 'armGroupLabels': ['Reproductive tract GBS colonization group of mothers during pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Qian Wang', 'role': 'STUDY_CHAIR', 'affiliation': 'Southern Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhongshan Bo Ai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}