Gut Microbiota and Metabolic Development in Early Childhood: A 3-Year Follow-Up Study
1 other identifier
observational
1,000
1 country
5
Brief Summary
This prospective observational birth cohort study aims to characterize the longitudinal development of the gut microbiome during early childhood and to investigate its associations with prenatal, perinatal, and postnatal exposures and child growth and health outcomes. Approximately 1000 pregnant women will be enrolled, and their children will be followed from birth to 36 months of age. Information on parental demographic and lifestyle characteristics, maternal pre-pregnancy and pregnancy-related factors, prenatal examinations, delivery characteristics, infant feeding, medication use, illnesses, and household and environmental factors will be collected through questionnaires and medical records. Child anthropometric measurements and fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age. The fecal microbiome will be characterized using shotgun metagenomic sequencing.Umbilical cord blood will be collected at delivery from all participants, subject to informed consent and hospital procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing will be retained for research from all participating children. The study will evaluate the developmental trajectories of the early-life gut microbiome and identify maternal, paternal, perinatal, feeding-related, medication-related, and environmental factors associated with microbiome development and subsequent child growth and health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2023
CompletedFirst Submitted
Initial submission to the registry
July 28, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 13, 2026
August 1, 2026
4.1 years
July 28, 2026
August 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in relative abundance of gut microbial taxa measured by shotgun metagenomic sequencing
Gut microbial taxonomic composition will be characterized from stool samples using shotgun metagenomic sequencing and summarized as the relative abundance of microbial taxa.
At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Secondary Outcomes (4)
Change in infant body weight measured by standardized follow-up records
At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Change in infant body length measured by standardized follow-up records
At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Change in infant head circumference measured by standardized follow-up records
At 1, 3, 6, 9, 12, 18, 24, 30, and 36 months after birth
Infant feeding pattern assessed by standardized follow-up questionnaire
At 1, 3, 6, 9, 12, 18, 24, 30, and 36 months after birth
Eligibility Criteria
Pregnant women and their newborns receiving care at maternal and child health hospitals in Yiyang, Jiangshan, Baoji, and Qidong
You may qualify if:
- Willing to undergo regular follow-up during the study period
You may not qualify if:
- Difficulty in follow-up participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Yiyang Maternal and Child Health Hospital
Yiyang, Hunan, 413000, China
Qidong Maternal and Child Health Hospital
Nantong, Jiangsu, 226200, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Baoji Maternal and Child Health Hospital
Baoji, Shanxi, 721099, China
Jiangshan Maternal and Child Health Hospital
Quzhou, Zhejiang, 324199, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Endocrinology
Study Record Dates
First Submitted
July 28, 2026
First Posted
August 13, 2026
Study Start
November 16, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 13, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share