Interactions Between Environmental Exposures and Gut Microbiota in Early Life

July 20, 2024 updated by: xu xue, Peking University People's Hospital

The Mechanism of Interaction Between Arsenic Exposure and Gut Microbiota in Infants During Early Life

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

756

Contacts and Locations

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

Study Contact

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 cohorts (Cesarean section)
Delivery mode, Cesarean section
Other: delivery mode
Based on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery.
Mother-infant cohorts (Natural delivery)
Delivery mode, Natural delivery
Other: delivery mode
Based on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arsenic levels and Gut microbiota
Time Frame: Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)
Arsenic levels in biological samples; gut microbiota and metabolites in stools.
Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 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)

July 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

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 23, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PKUPH-X1

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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