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Gut Microbiota and Metabolic Development in Early Childhood: A 3-Year Follow-Up Study

NCT07762729 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Gut Microbiota
  • Early Child Development

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Eligibility

Min Age
0 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762729 on ClinicalTrials.gov