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NCT Number: NCT05462366

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.

Recruiting

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Key information

Age range

Up to 40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Ying Ma, Doctor

CONTACT

[email protected]

13113361169

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

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

Primary outcomes

  1. Compare the omics differences of the specimens between the experimental and control groups

    Time frame: 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.

  2. Compare the microbial feature differences of the specimens between the experimental and control groups

    Time frame: 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 outcomes

  1. Compare the health status differences between the experimental and control groups

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Ma, Doctor

CONTACT

[email protected]

13113361169

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jul 18, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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