Antibiotics Affecting Newborn Gut MicrobiotaNCT06479941
Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota
An observational study of Antibiotics Affecting Newborn Gut Microbiota, run by Peking University People's Hospital at 1 site in China.
Trial summary
Based on a prospective birth cohort, the investigators will collect biological samples from participants including pregnant women and newborns, to measure the gut microbial diversity and metabolites of newborns. Read more about this study
- Who is it for?
- Ages 1 day to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Antibiotics Affecting Newborn Gut Microbiota
- What is being tested?
- antibiotic treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 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.
China1 site, 1 recruiting
- Recruiting
The Peking University People's Hospital
Beijing
Xue Xu, Dr., 010-88324385, xuxue19877182@sina.com
About this study
Based on a prospective birth cohort, the investigators will collect biological samples from participants including pregnant women and newborns, to measure the gut microbial diversity and metabolites of newborns. These results systematically evaluate the effects of antibiotic exposure on the structure and function of gut microbiota. The project can reveal the effects of antibiotic exposure on the growth and development of gut microbiota in early life.
- Being tested
- antibiotic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic treatmentOther
AT: Mother-infant cohort with antibiotic treatment group CS: Mother-infant cohort (Prophylactic antibiotics therapy) ND: Mother-infant cohort (Natural delivery)
| Study group | Role | What they receive |
|---|---|---|
| Mother-infant cohort with antibiotic treatment group | E.g., Bacterial infection during pregnancy Receives: Other: antibiotic treatment | |
| Mother-infant cohort (Prophylactic antibiotics therapy) | E.g., cesarean section Receives: Other: antibiotic treatment | |
| Mother-infant cohort (Natural delivery) | E.g., Natural delivery Receives: Other: antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant gut microbiome
- Diversity of gut microbiota
- Abundance of antibiotic resistance genes in gut microbiota
- Metabolic pathway of gut microbiota
Measured: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
Secondary outcomes (1)
Antibiotic treatment
- Frequency of antibiotic treatment
- Kind and Dose of antibiotic;
- Duration of antibiotic use;
Measured: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 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 start25 Jun 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotics Affecting Newborn Gut MicrobiotaStudies 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
- 450 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
- NCT06479941
- Sponsor's protocol ID
- PKUPH-X2
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 24 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota
- ClinicalTrials.gov ID
- NCT06479941
- Acronym / sponsor ID
- PKUPH-X2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (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.
Based on a prospective birth cohort, the investigators will collect biological samples from participants including pregnant women and newborns, to measure the gut microbial diversity and metabolites of newborns. These results systematically evaluate the effects of antibiotic exposure on the structure and function of gut microbiota. The project can reveal the effects of antibiotic exposure on the growth and development of gut microbiota in early life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mother-infant cohort with antibiotic treatment group | – | Other: antibiotic treatmentE.g., Bacterial infection during pregnancy |
| Mother-infant cohort (Prophylactic antibiotics therapy) | – | Other: antibiotic treatmentE.g., cesarean section |
| Mother-infant cohort (Natural delivery) | – | Other: antibiotic treatmentE.g., Natural delivery |
Who may qualify
- Ages
- 1 day to 12 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 |
|---|---|---|
| antibiotic treatmentAT: Mother-infant cohort with antibiotic treatment group CS: Mother-infant cohort (Prophylactic antibiotics therapy) ND: Mother-infant cohort (Natural delivery) | Other | Mother-infant cohort (Natural delivery), Mother-infant cohort (Prophylactic antibiotics therapy), Mother-infant cohort with antibiotic treatment group |
Primary outcome
Infant gut microbiome
Time frame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
* Diversity of gut microbiota * Abundance of antibiotic resistance genes in gut microbiota * Metabolic pathway of gut microbiota
1 secondary outcome
Antibiotic treatment
Time frame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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. This study is not recruiting at the moment.
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 Antibiotics Affecting Newborn Gut Microbiota, 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: status not confirmed, as of the sponsor's last update on 24 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant gut microbiome (time frame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 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 24 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.