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临床试验/NCT02797756
NCT02797756已完成不适用

Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年8月5日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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