Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

• Sponsor: Zhujiang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05462366
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 66.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The investigators aim to collect breaskmilk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signiture of the specimens.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Breastmilk Collection; Feces	Other: Sample collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Family-Based
• Time Perspective: Prospective
• Official Title: Omics Sequencing of Specimen Derived From Mother-Infant-Pairs
• Actual Study Start Date: Jun 22, 2021
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Mother healthy mothers	Other: Sample collection; Collect breaskmilk and feces from mother-infant-pairs.
Infant healthy infants	Other: Sample collection; Collect breaskmilk and feces from mother-infant-pairs.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ma Ying, Clinical Professor, Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT05462366
• Other Study ID Numbers: ZhujiangHFCYXZX
• First Posted: Jul 18, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 18, 2022