跳至主要内容
临床试验/DRKS00022267
DRKS00022267已完成4 期

OrkambiKIDS: Impact of CFTR-modulation with Lumacftor/Ivacaftor on the intestinal and respiratory microbiome and microbial metabolites in children aged 2 to 12 with cystic fibrosis - OrkambiKIDS

Children's Hospital, University medical center Mainz0 个研究点目标入组 8 人开始时间: 2020年10月26日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
8

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
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
2 Years 至 12 Years(—)
性别
All

入选标准

  • Confirmed CF-diagnosis and mutation
  • Planned to start medication with Lumacftor/Ivacaftor
  • Written informed consent from parent or legal guardian

排除标准

  • Comorbidity which exclude therapy with Lumacaftor/Ivacaftor (e.g liver or renal insufficiency)
  • Clinically significant abnormality
  • Respiratory infection at the start of treatment
  • Pulmonary infection with resistant strain of bacteria

研究者

发起方
Children's Hospital, University medical center Mainz

相似试验