Infant DevelopmentNCT06479928
Interactions Between Environmental Exposures and Gut Microbiota in Early Life
An observational study of Infant Development, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- delivery mode
- How many people
- 756 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pregnant woman registered in Peking University People's Hospital will plan to give birth in the hospital.
Who may be able to join
- Pregnant woman
- aged 20-40 years old
- natural conception
- single pregnancy
- gestational age ≥36 weeks
- Newborn
- normal Apgar score
- no serious congenital diseases
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Peking University People's Hospital
Beijing
Xue Xu, Dr., 010-88324385, xuxue19877182@sina.com
About this study
Official title: 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.
- Conditions
- Infant Development
- Being tested
- delivery mode
- Keywords
- environmental exposure, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delivery modeOther
Based on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery.
| Study group | Role | What they receive |
|---|---|---|
| Mother-infant cohorts (Cesarean section) | Delivery mode, Cesarean section Receives: Other: delivery mode | |
| Mother-infant cohorts (Natural delivery) | Delivery mode, Natural delivery Receives: Other: delivery mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arsenic levels and Gut microbiota
Arsenic levels in biological samples; gut microbiota and metabolites in stools.
Measured: Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xu xue, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479928
- Sponsor's protocol ID
- PKUPH-X1
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Interaction Between Arsenic Exposure and Gut Microbiota in Infants During Early Life
- ClinicalTrials.gov ID
- NCT06479928
- Acronym / sponsor ID
- PKUPH-X1
- Conditions
- Infant Development
- Keywords
- environmental exposure, gut microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mother-infant cohorts (Cesarean section) | – | Other: delivery modeDelivery mode, Cesarean section |
| Mother-infant cohorts (Natural delivery) | – | Other: delivery modeDelivery mode, Natural delivery |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pregnant woman registered in Peking University People's Hospital will plan to give birth in the hospital.
Key inclusion criteria (8 listed)
- Pregnant woman
- Newborn
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delivery modeBased on delivery mode, we will divide them into two groups, including Cesarean section and Natural delivery. | Other | Mother-infant cohorts (Cesarean section), Mother-infant cohorts (Natural delivery) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Xu, Dr. (010-88324385, xuxue19877182@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arsenic levels and Gut microbiota (time frame: Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.