Interactions Between Environmental Exposures and Gut Microbiota in Early Life
The Mechanism of Interaction Between Arsenic Exposure and Gut Microbiota in Infants During Early Life
1 other identifier
observational
756
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 24, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
July 23, 2024
July 1, 2024
3.4 years
June 24, 2024
July 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Arsenic levels and Gut microbiota
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)
Study Arms (2)
Mother-infant cohorts (Cesarean section)
Delivery mode, Cesarean section
Mother-infant cohorts (Natural delivery)
Delivery mode, Natural delivery
Interventions
Based on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery.
Eligibility Criteria
Pregnant woman registered in Peking University People's Hospital will plan to give birth in the hospital.
You may qualify if:
- Pregnant woman
- aged 20-40 years old
- natural conception
- single pregnancy
- gestational age ≥36 weeks
- Newborn
- normal Apgar score
- no serious congenital diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Peking University People's Hospital
Beijing, China
Biospecimen
mother-infant stools, umbilical cord blood, placenta and hairs.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chief Physician
Study Record Dates
First Submitted
June 24, 2024
First Posted
June 28, 2024
Study Start
July 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
July 23, 2024
Record last verified: 2024-07