Probiotics After Discharge (PAD) Study: Impact on Microbiome, Health and Growth Outcomes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Microbiome
研究概览
简要总结
The influence of the preterm gut microbiota in health and disease has been well established. However, relatively little is known about how the microbiome changes after discharge and its relationship with growth, health and disease outcomes in the preterm population. This study aims to follow a cohort of preterm infants and explore the relationship of the later microbiome ('after discharge') with later growth and health outcomes in infancy. The study will also explore the effect of timing of stopping routinely administered probiotics on the post-discharge microbiome, infant feeding and outcomes such as colic.
The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The investigators will collect stool at and beyond the time of anticipated discharge (beyond 34 weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge timing of these infants varies, and is usually latest in the most immature infants, allowing an assessment of the influence of physical location (NICU vs home) as well as increasing age. Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial colonisation of the gut and measure infant weight, length and head circumference at each time point. The investigators will use a parent questionnaire to assess daily crying time, parents' perceptions of colic severity using a visual analogue scale as well as vomiting and constipation for the two weeks before sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 32 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<32 weeks Corrected Gestation
- •Followed up in Newcastle Region
排除标准
- 未提供
结局指标
主要结局
Microbiome
时间窗: one year
16S RNA assessed using illumina sequencer
次要结局
- Growth Velocity(1 year)
- Growth: Length(1 year)
- Head Growth(1 year)
