Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
研究概览
简要总结
With this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. To achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. Secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. Bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis patients
- •>6 years for intervention part of the study
排除标准
- 未提供
结局指标
主要结局
Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
时间窗: Change of microbial composition over one year (observational)
Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray
时间窗: Transfer of probiotic over 6 weeks
qPCR
次要结局
- Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in saliva, oropharynx and sputum samples, and cytokine and antibody levels in blood samples(Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks)
- Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray(Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks)
- Influence on general health(Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks)
研究者
Kim Van Hoorenbeeck
Prof. dr.
University Hospital, Antwerp