NCT06479941

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 25, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

June 24, 2024

Last Update Submit

July 22, 2024

Conditions

Antibiotics Affecting Newborn Gut Microbiota

Outcome Measures

Primary Outcomes (1)

  • Infant gut microbiome

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

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

Secondary Outcomes (1)

  • Antibiotic treatment

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

Study Arms (3)

Mother-infant cohort with antibiotic treatment group

E.g., Bacterial infection during pregnancy

Other: antibiotic treatment

Mother-infant cohort (Prophylactic antibiotics therapy)

E.g., cesarean section

Other: antibiotic treatment

Mother-infant cohort (Natural delivery)

E.g., Natural delivery

Other: antibiotic treatment

Interventions

antibiotic treatmentOTHER

AT: Mother-infant cohort with antibiotic treatment group CS: Mother-infant cohort (Prophylactic antibiotics therapy) ND: Mother-infant cohort (Natural delivery)

Mother-infant cohort (Natural delivery)Mother-infant cohort (Prophylactic antibiotics therapy)Mother-infant cohort with antibiotic treatment group

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pregnant woman registered in Peking University People's Hospital will plan to give birth in the hospital.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Peking University People's Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Umbilical cord blood, placenta, stool

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chief Physician

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

June 25, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

CN(1)