Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

Recruiting

• Conditions: Healthy; Breast-milk Collection; Feces
• Interventions: Other: Sample collection

• Registration Number: NCT05462366
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-22
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-22
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• healthy pregnant women aged between 20y and 40y.
• Vaginal birth
• BMI<23.5 before pregnancy
• Infants' birth weight, between 2500g and 4000g.

Exclusion Criteria

• gestational diabetes
• diagnosis of depressive disorder during pregnancy
• gestational hypertension
• diagnosis of other diseases during pregnancy
• Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery
• histrory of smoking and drinking alcohol
• history of diarrhea from 3 months prior to pregnancy till 3 months after delivery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mother	Sample collection	healthy mothers
Infant	Sample collection	healthy infants

Primary Outcome Measures

Name	Time	Method
Compare the omics differences of the specimens between the experimental and control groups	2021.7.1-2026.12.30	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.
Compare the microbial feature differences of the specimens between the experimental and control groups	2021.7.1-2026.12.30	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.

Secondary Outcome Measures

Name	Time	Method
Compare the health status differences between the experimental and control groups	2021.7.1-2026.12.30	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.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China