Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- changes in gut microbiota over time and in relation to antibiotic treatment
研究概览
简要总结
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.
The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.
详细描述
Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .
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
- 1 Day 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants
- •gestational age <37 weeks;
- •no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
- •hospital stay > 7 days;
- •Exclusion criteria:
- •NICU stay less than 7 days
- •Necrotizing enterocolitis infant
- •Control group:
- •Full-term healthy infants;
- •gestational age >37 weeks;
- •vaginally born;
- •no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.
排除标准
- 未提供
结局指标
主要结局
changes in gut microbiota over time and in relation to antibiotic treatment
时间窗: 0-7 years after birth
Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants
次要结局
未报告次要终点