Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota

NCT ID: NCT06479941

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-25

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Antibiotics Affecting Newborn Gut Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mother-infant cohort with antibiotic treatment group

E.g., Bacterial infection during pregnancy

antibiotic treatment

Intervention Type OTHER

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

antibiotic treatment

Intervention Type OTHER

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

antibiotic treatment

Intervention Type OTHER

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

Interventions

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antibiotic treatment

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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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xu xue

Vice Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xue Xu, Dr.

Role: primary

010-88324385

Other Identifiers

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PKUPH-X2

Identifier Type: -

Identifier Source: org_study_id

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