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Clinical Trials/NCT06479941
NCT06479941
Recruiting
Not Applicable

Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota

Peking University People's Hospital1 site in 1 country450 target enrollmentJune 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antibiotics Affecting Newborn Gut Microbiota
Sponsor
Peking University People's Hospital
Enrollment
450
Locations
1
Primary Endpoint
Infant gut microbiome
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Based on a prospective birth cohort, the investigators will collect biological samples from participants including pregnant women and newborns, to measure the gut microbial diversity and metabolites of newborns. These results systematically evaluate the effects of antibiotic exposure on the structure and function of gut microbiota. The project can reveal the effects of antibiotic exposure on the growth and development of gut microbiota in early life.

Registry
clinicaltrials.gov
Start Date
June 25, 2023
End Date
August 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

xu xue

Vice Chief Physician

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Pregnant woman
  • aged 20-40 years old
  • natural conception
  • single pregnancy
  • gestational age ≥36 weeks
  • normal Apgar score
  • no serious congenital diseases

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Infant gut microbiome

Time Frame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)

* Diversity of gut microbiota * Abundance of antibiotic resistance genes in gut microbiota * Metabolic pathway of gut microbiota

Secondary Outcomes

  • Antibiotic treatment(Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months))

Study Sites (1)

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