Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis
研究概览
简要总结
The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, newborn to age 3 months
- •Have a diagnosis of cystic fibrosis (Diagnosis of CF will be based on either a positive sweat chloride of >60 mEq/L or the identification of two detectable mutations associated with CF
- •Parent/guardian plans to have follow-up care for approximately one year at designated CF clinic
- •Parent/guardian provides informed consent to participate in the study
排除标准
- •Contraindications for obtaining oropharyngeal swabs
结局指标
主要结局
To characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis
时间窗: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To describe the clinical variables that may be associated with changes in microbial ecology in children with cystic fibrosis over the first year of life
时间窗: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To explore changes in the microbial ecology of the oropharynx in conjunction with Staphylococcus aureus colonization in children with CF
时间窗: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
次要结局
未报告次要终点