Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

NCT05462366 | Recruiting

• 1 other identifier: ZhujiangHFCYXZX
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Breast-milk Collection; Feces

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Compare the health status differences between the experimental and control groups

  2021.7.1-2026.12.30

Study Arms (2)

Mother

healthy mothers

Other: Sample collection

Infant

healthy infants

Other: Sample collection

Interventions

Sample collection OTHER

Collect breast-milk and feces from mother-infant-pairs.

Infant; Mother

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Breastmilk and feces from mother-infant-pairs

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Ying Ma, Doctor

CONTACT

13113361169; mayingwuzhuoyi@126.com

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 18, 2022
• Study Start: June 22, 2021
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

CN (1)