Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
Effects of Early Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns: a Prospective Cohort Study
1 other identifier
observational
200
1 country
1
Brief Summary
This prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants. The study will explore the correlation between antibiotic exposure, gut microbiota colonization, and 5-hydroxytryptamine (5-HT) levels, which are critical for gastrointestinal motility. The findings may provide insights into optimizing antibiotic use and improving gastrointestinal health in neonates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 26, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
February 28, 2025
February 1, 2025
2.3 years
February 26, 2025
February 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
gut microbiota
Impact of antibiotic exposure on gut microbiota colonization assessed by 16S rRNA sequencing.
Enrollment Period: This is the time during which participants will be recruited and enrolled into the study. You have specified that enrollment will occur from November 2024 to November 2027. Intervention Period: Since this is an observational study, the
Study Arms (1)
Preterm Infants with Antibiotic Exposure
Description: Newborns with gestational age 24-36 weeks who receive antibiotics within the first 72 hours of life.
Eligibility Criteria
This study will enroll newborns admitted to the neonatal unit of Jilin University First Hospital from November 2024 to November 2027.
You may qualify if:
- Newborns admitted within 72 hours of birth
- Gestational age 24-36 weeks (preterm) and term infants
- Informed consent obtained from parents or guardian
You may not qualify if:
- Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease)
- Severe systemic or organ-specific diseases
- Expected mortality due to severe illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first hospital of Jilin university
Changchun, Jilin, 130021, China
Related Publications (1)
Jiang S, Zhang L, Yan W, Li S, Han J, Zhou Q, Yang Y, Lee SK, Cao Y; REIN-EPIQ Study Group. Antibiotic Use in Neonatal Intensive Care Units in China: A Multicenter Cohort Study. J Pediatr. 2021 Dec;239:136-142.e4. doi: 10.1016/j.jpeds.2021.08.067. Epub 2021 Aug 28.
PMID: 34461063BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2025
First Posted
February 28, 2025
Study Start
February 1, 2025
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share