Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- respiratory microbiome
研究概览
简要总结
Respiratory und intestinal microbiome will bei analyzed during a period of 6 months. In a retrospective analysis it will be looked for correlations between microbiome and cf therapy (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump Inhibitors, enzymes, nutritional habits), clinical status and self reported outcome.
详细描述
DNA will be isolated from sputum, throat swabs and stool samples and used for the generation of microbial profiles. Both bacterial and fungal profiles will be analyzed by next generation sequencing.
Clinical outcome parameters (lung function test, weight, calprotectin, elastase, blood parameters, self reported outcome) will be recorded and analyzed along with medication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject has confirmed diagnosis of cystic fibrosis (sweat chloride >60mmol/l and/or 2 mutations in the cftr gene known to cause cystic fibrosis)
- •subject is able to perform informed consent
排除标准
- •inability to give informed consent
- •antibiotic therapy in the last 4 weeks prior to study start (exception: long term azithromycin therapy, long term antistaphylococcal therapy, long term inhaled antibiotics)
结局指标
主要结局
respiratory microbiome
时间窗: 24 weeks
abundance \[operational taxonomic units\]
intestinal microbiome
时间窗: 24 weeks
abundance \[operational taxonomic units\]
次要结局
- Forced Exspiratory Volume FEV1 [%pred](24 weeks)
- weight (kg)(24 weeks)
- Quality of life [score](24 weeks)
研究者
Ingrid Bobis
Dr. med., Oberärztin für Pneumologie, Head of Adult CF Centre UKSH Kiel, Klinik für Innere Medizin I UKSH Kiel
University of Kiel