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RecruitingNCT06479928Updated Jul 23, 2024

Interactions Between Environmental Exposures and Gut Microbiota in Early Life

An observational study in Infant Development, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 1 Day to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Peking University People's Hospital · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
756
Ages
1 Day to 24 Months
Sex
All
01

Study summary

Recruit the mothers and their infants who bron in Peking University People's Hospital from 2023 to 2026, to evaluate the interaction between environmental exposure and gut microbiota.

02

Conditions studied

  • Infant Development

Keywords

  • environmental exposure
  • gut microbiota
03

In context

Lead sponsor

Peking University People's Hospital is the lead sponsor of 604 studies on the registry; 242 are open to participants now.

Browse Peking University People's Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 24 Months
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
756 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Mother-infant cohorts (Cesarean section)

    Delivery mode, Cesarean section

    Other: delivery mode

  • Mother-infant cohorts (Natural delivery)

    Delivery mode, Natural delivery

    Other: delivery mode

Interventions

  • Otherdelivery mode

    Based on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery.

06

What researchers measure

Primary outcomes

  1. Arsenic levels and Gut microbiota

    Arsenic levels in biological samples; gut microbiota and metabolites in stools.

    Time frame: Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)

07

Study locations

1 of 1 sites recruiting
  • The Peking University People's Hospital
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06479928
Lead sponsor
Peking University People's Hospital
Responsible party
xu xue (Vice Chief Physician, Peking University People's Hospital) — Principal investigator
First posted
Jun 28, 2024
Start date
Jul 1, 2023
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 23, 2024

Study contacts

Xue Xu, Dr.
Contact
xuxue19877182@sina.com
010-88324385

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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