Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-28 @ 2:38 PM
Study NCT ID:
NCT05462366
Status:
RECRUITING
Last Update Posted:
2023-07-25
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omics Sequencing of Specimen Derived From Mother-Infant-Pairs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}], 'ancestors': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Breastmilk and feces from mother-infant-pairs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-22', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the omics differences of the specimens between the experimental and control groups', 'timeFrame': '2021.7.1-2026.12.30', 'description': 'Apply 16S amplicon sequencing and shotgun sequencing technology to obtain microbial structure of the specimens. The differences of microbial structure will be compared between the experimental and control groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value \\> 0.05 in LSD test.'}, {'measure': 'Compare the microbial feature differences of the specimens between the experimental and control groups', 'timeFrame': '2021.7.1-2026.12.30', 'description': "Apply traditional culture technologies to validate and obtain human source bacteria.The differences of frequencies of probiotics will be compared between the experimental and control groups. Depending on the distribution of the variables, either the Mann-Whitney test or the unpaired Student's t-test was employed for quantitative variables. The Kruskal-Wallis test for mean values was used to evaluate non-parametric comparisons between participants in all groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value \\> 0.05 in LSD test."}], 'secondaryOutcomes': [{'measure': 'Compare the health status differences between the experimental and control groups', 'timeFrame': '2021.7.1-2026.12.30', 'description': "After a brief introduction to the survey, participants were asked to complete a questionnaire. The differences of health status will be compared between the experimental and control groups. Depending on the distribution of the variables, either the Mann-Whitney test or the unpaired Student's t-test was employed for quantitative variables. The Kruskal-Wallis test for mean values was used to evaluate non-parametric comparisons between participants in all groups."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Breast-milk Collection', 'Feces']}, 'descriptionModule': {'briefSummary': 'The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study intends to screen pregnant women in the Obstetrics and Gynecology Center of Zhujiang Hospital, Southern Medical University, and preliminarily recruit subjects that meet the inclusion criteria according to clinical diagnosis and auxiliary examination results. According to the specific conditions of vaginal delivery and post-birth newborns, the final inclusion of healthy pregnant women and newborns will be determined, and a total of 40-50 mother-infant-pairs will be recruited', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy pregnant women aged between 20y and 40y.\n* Vaginal birth\n* BMI\\<23.5 before pregnancy\n* Infants' birth weight, between 2500g and 4000g.\n\nExclusion Criteria:\n\n* gestational diabetes\n* diagnosis of depressive disorder during pregnancy\n* gestational hypertension\n* diagnosis of other diseases during pregnancy\n* Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery\n* histrory of smoking and drinking alcohol\n* history of diarrhea from 3 months prior to pregnancy till 3 months after delivery"}, 'identificationModule': {'nctId': 'NCT05462366', 'briefTitle': 'Omics Sequencing of Specimen Derived From Mother-Infant-Pairs', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Omics Sequencing of Specimen Derived From Mother-Infant-Pairs', 'orgStudyIdInfo': {'id': 'ZhujiangHFCYXZX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mother', 'description': 'healthy mothers', 'interventionNames': ['Other: Sample collection']}, {'label': 'Infant', 'description': 'healthy infants', 'interventionNames': ['Other: Sample collection']}], 'interventions': [{'name': 'Sample collection', 'type': 'OTHER', 'description': 'Collect breast-milk and feces from mother-infant-pairs.', 'armGroupLabels': ['Infant', 'Mother']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Ma, Doctor', 'role': 'CONTACT', 'email': 'mayingwuzhuoyi@126.com', 'phone': '13113361169'}], 'facility': 'Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ying Ma, Doctor', 'role': 'CONTACT', 'email': 'mayingwuzhuoyi@126.com', 'phone': '13113361169'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ma Ying', 'investigatorAffiliation': 'Zhujiang Hospital'}}}}