Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

Healthy Clinical Trial

Official title:

Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462366
• Other study ID #: ZhujiangHFCYXZX
• Status: Recruiting
• Start date: June 22, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: July 2023
• Source: Zhujiang Hospital
• Contact: Ying Ma, Doctor
• Phone: 13113361169
• Email: mayingwuzhuoyi[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Sample collection
Collect breast-milk and feces from mother-infant-pairs.

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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