Clinical Research Directory

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

Sponsor: Children's Hospital of Fudan University

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.

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