Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group
研究概览
简要总结
Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be performed, investigators will conduct a chart review to obtain relevant clinical data and the investigators will use an aliquot of airway sample obtained during the clinically indicated bronchoscopy for microbiome analysis. A case-control study design will be used to study whether subjects with CC with GER have a distinct lung microbiome and increased inflammation as compared with subjects with CC without GER and to determine whether the microbiome and degree of inflammation is related to the type of GER (acidic versus nonacidic).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 24 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
排除标准
- •Antibiotic or steroids (inhaled or systemic) use within the prior one-week. Rationale: Antibacterial drugs and immune-modulators are confounders that may impact the microbiome and inflammation. While longer period free of Antibacterial drugs and immune-modulators would be desired, it would be unethical and it is not the usual standard of care to withdraw treatment for longer periods of time.
- •Interstitial Lung Disease or pneumonia on X-ray
- •Cystic fibrosis
- •Primary ciliary dyskinesia
- •Immunodeficiency syndromes
- •Major airway abnormalities
- •Proton pump inhibitor/H2-receptor antagonist therapy within the prior 2 weeks
结局指标
主要结局
Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group
时间窗: 2 Years
Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group
时间窗: 2 Years
次要结局
未报告次要终点
