Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
Completed
Conditions studied: Chronic Cough (CC), Gastroesophageal Reflux (GER)
In brief
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).
Key facts
- Study ID
- NCT02797756
- Run by
- NYU Langone Health
- People needed
- 35
- Starts
- 2014-08-05
- Expected to finish
- 2018-12-12
- Last updated by the study team
- 2019-01-29
Who can join
Age: any, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
You may not qualify if…
- 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
Where it is running
- New York University School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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