Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

NEC - Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

24 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hospital of Jilin university

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

gut microbiota

Time frame: 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

Impact of antibiotic exposure on gut microbiota colonization assessed by 16S rRNA sequencing.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

Effects of Early Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns: a Prospective Cohort Study

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Feb 28, 2025
Registry last updated: Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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