Gut Microbiota and Metabolic Development in Early Childhood: A 3-Year Follow-Up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 1,000
- Locations
- 5
- Primary Endpoint
- Change in relative abundance of gut microbial taxa measured by shotgun metagenomic sequencing
Study Overview
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.
Detailed Description
Early childhood is a critical period for the establishment and maturation of the gut microbiome. Microbiome development during this period may be influenced by maternal health, pregnancy-related factors, mode of delivery, gestational age, infant feeding, medication exposure, infections, household conditions, and other early-life exposures.
This prospective, longitudinal, observational birth cohort study will recruit approximately 1000 pregnant women and follow their children from birth to 36 months of age. No intervention will be assigned by the investigators, and participants will receive routine maternal and child healthcare according to local clinical practice.
Information on parental demographic, health, anthropometric, and lifestyle characteristics; maternal pre-pregnancy and pregnancy-related factors; prenatal examinations; delivery and neonatal characteristics; infant feeding and diet; medication use; illnesses; vaccination; hospitalization; and household and environmental factors will be collected through questionnaires and medical records. Child growth will be assessed using standardized anthropometric measurements.
Fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age using standardized procedures. Shotgun metagenomic sequencing will be used to characterize the taxonomic composition and functional potential of the gut microbiome and to evaluate its longitudinal developmental patterns.
Umbilical cord blood collection will be planned at delivery for all participants, subject to informed consent, collection feasibility, and institutional procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing may be retained for research. All biological specimens will be processed and stored according to standardized operating procedures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Months to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Willing to undergo regular follow-up during the study period
Exclusion Criteria
- •Difficulty in follow-up participation
Outcomes
Primary Outcomes
Change in relative abundance of gut microbial taxa measured by shotgun metagenomic sequencing
Time Frame: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Gut microbial taxonomic composition will be characterized from stool samples using shotgun metagenomic sequencing and summarized as the relative abundance of microbial taxa.
Secondary Outcomes
- 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)
Investigators
Feihong Luo
Director, Department of Endocrinology
Children's Hospital of Fudan University