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Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05462366
Enrollment
100
Registered
2022-07-18
Start date
2021-06-22
Completion date
2026-12-30
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast-milk Collection, Feces, Healthy

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.

Interventions

OTHERSample collection

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

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Compare the omics differences of the specimens between the experimental and control groups2021.7.1-2026.12.30Apply 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 groups2021.7.1-2026.12.30Apply 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

MeasureTime frameDescription
Compare the health status differences between the experimental and control groups2021.7.1-2026.12.30After 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.

Countries

China

Contacts

Primary ContactYing Ma, Doctor
mayingwuzhuoyi@126.com13113361169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026