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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06850896
Enrollment
200
Registered
2025-02-28
Start date
2025-02-01
Completion date
2027-05-30
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NEC - Necrotizing Enterocolitis

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.

Interventions

None listed

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 36 Weeks
Healthy volunteers
No

Inclusion criteria

* Newborns admitted within 72 hours of birth * Gestational age 24-36 weeks (preterm) and term infants * Informed consent obtained from parents or guardian

Exclusion criteria

* Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease) * Severe systemic or organ-specific diseases * Expected mortality due to severe illness

Design outcomes

Primary

MeasureTime frameDescription
gut microbiotaEnrollment 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, theImpact of antibiotic exposure on gut microbiota colonization assessed by 16S rRNA sequencing.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026