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临床试验/ACTRN12616000797471
ACTRN12616000797471招募中未知

Probiotics and the EARly Life effects on intestinal bacteria and inflammation in children with Cystic Fibrosis (PEARL-CF”)

Sydney Children's Hospitals Network0 个研究点目标入组 128 人开始时间: 2016年6月17日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
128

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
o limit 至 6 Years(—)
性别
All

入选标准

  • (1) All subjects with CF must fulfil the diagnostic criteria for CF (sweat chloride greater or equal to 60 mmol/L and/or 2 CF-causing mutations).
  • (2) Healthy controls include healthy full term infants (38-40 weeks gestation; >2.5kg birth weight), and who do not have any major non-CF disease (e.g. spina bifida) or gut disease (e.g. inflammatory bowel disease).

排除标准

  • 1) Patients with CF who have had previous intestinal surgery (e.g. meconium ileus) and/or have intestinal resection resulting in short gut syndrome.
  • (2) Any CF subject already on probiotics but who are not willing to stop supplementation for 3 months prior to randomization.
  • (3) Healthy controls on probiotics who are not willing to stop.

研究者

发起方
Sydney Children's Hospitals Network

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