Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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NEC - Necrotizing Enterocolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Infants with Antibiotic Exposure

Description: Newborns with gestational age 24-36 weeks who receive antibiotics within the first 72 hours of life.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No