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
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