Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Feces; Breast-milk Collection
• Intervention / Treatment: Other: Sample collection

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ying Ma, Doctor; Phone Number: 13113361169; Email: mayingwuzhuoyi@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhujiang Hospital
      • Contact: Ying Ma, Doctor; Phone Number: 13113361169; Email: mayingwuzhuoyi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mother; healthy mothers	Other: Sample collection; Collect breast-milk and feces from mother-infant-pairs.
Infant; healthy infants	Other: Sample collection; Collect breast-milk and feces from mother-infant-pairs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the omics differences of the specimens between the experimental and control groups	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.	2021.7.1-2026.12.30
Compare the microbial feature differences of the specimens between the experimental and control groups	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.	2021.7.1-2026.12.30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the health status differences between the experimental and control groups	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.	2021.7.1-2026.12.30

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ZhujiangHFCYXZX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No