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临床试验/NCT02695784
NCT02695784Unknown4 期

Probiotics After Discharge (PAD) Study: Impact on Microbiome, Health and Growth Outcomes

Newcastle-upon-Tyne Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月1日最近更新:
适应症

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

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)

研究者

发起方
Newcastle-upon-Tyne Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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