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临床试验/NCT06850896
NCT06850896进行中(未招募)不适用

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

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
gut microbiota

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
24 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

gut microbiota

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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