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
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
- Name: Xue Xu, Dr.
- Phone Number: 010-88324385
- Email: xuxue19877182@sina.com
Study Locations
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-
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Beijing, China
- Recruiting
- The Peking University People's Hospital
-
Contact:
- Xue Xu, Dr.
- Phone Number: 010-88324385
- Email: xuxue19877182@sina.com
-
-
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:
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:
-
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 |
|---|---|
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Mother-infant cohorts (Cesarean section)
Delivery mode, Cesarean section
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Based on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery.
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Mother-infant cohorts (Natural delivery)
Delivery mode, Natural delivery
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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)
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Arsenic levels in biological samples; gut microbiota and metabolites in stools.
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Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.