跳至主要内容
临床试验/NCT03340259
NCT03340259Unknown不适用

Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition

研究概览

简要总结

The human microbiota, a collection of microorganisms mostly settled in the gastrointestinal tract, plays a major role in the maintenance of the hosts' health and in development of disease as well. Exposure to different conditions early in life contributes to distinct "pioneer" bacterial communities, which shape the newborn infants' development and influence their later physiological, immunological and neurological homeostasis. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotizing enterocolitis (NEC), and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. While intestinal microbiota has been extensively studied in infants with anatomically uninterrupted intestine, the knowledge of longitudinal intestinal colonization in this population is scarce.

This is an exploratory, observational, and longitudinal prospective study, primarily aimed to determine longitudinally the colonization of the proximal remnant intestine, in newborn infants with enterostomy after surgery (three weeks) for CMGIT, NEC and SIP. The secondary aim is to explore the associations of the colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, H2-receptor antagonist therapy, and length of proximal remnant intestine.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition

时间窗: The first sample will be collected as close as possible after placement of ostomy bag. From the first collection, new samples will be collected every 3 days, until the 21st day after surgery

Longitudinal postsurgical microbiota colonization of the proximal remnant intestine, specific to each underlying condition

次要结局

  • Associations of types of microorganism identified with below defined clinical variables(The aforementioned clinical variables will be collected daily and the enterostomy effluent collected from the first placement of ostomy bag and every 3 days thereafter up to 21 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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