Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota

July 22, 2024 updated by: xu xue, Peking University People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • The Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Pregnant woman

    • aged 20-40 years old
    • natural conception
    • single pregnancy
    • gestational age ≥36 weeks

  2. Newborn

    • normal Apgar score
    • no serious congenital diseases

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mother-infant cohort with antibiotic treatment group
E.g., Bacterial infection during pregnancy
Other: antibiotic treatment
AT: Mother-infant cohort with antibiotic treatment group CS: Mother-infant cohort (Prophylactic antibiotics therapy) ND: Mother-infant cohort (Natural delivery)
Mother-infant cohort (Prophylactic antibiotics therapy)
E.g., cesarean section
Other: antibiotic treatment
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)
E.g., Natural delivery
Other: antibiotic treatment
AT: Mother-infant cohort with antibiotic treatment group CS: Mother-infant cohort (Prophylactic antibiotics therapy) ND: Mother-infant cohort (Natural delivery)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic treatment
Time Frame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
  • Frequency of antibiotic treatment
  • Kind and Dose of antibiotic;
  • Duration of antibiotic use;
Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-X2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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