Recruiting

NCT Number: NCT06479941

Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota

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.

Recruiting

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Key information

Conditions

Antibiotics Affecting Newborn Gut Microbiota

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Peking University People's Hospital

Beijing, China

Location status: Recruiting

Location contact

Xue Xu, Dr.

CONTACT

[email protected]

010-88324385

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant woman

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

normal Apgar score
no serious congenital diseases

Exclusion criteria

Treatment and study plan

antibiotic treatment

Other

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

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

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;

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital