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

Study Overview
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Brief Summary
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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).

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

Conditions
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Chronic Cough (CC), Gastroesophageal Reflux (GER)

Intervention / Treatment
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* Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy
* Procedure: Esophageal Impedance Monitoring (EIM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks). Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>CC/GER+ presence of chronic cough and presence of GER evidenced by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM) | Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy<br> <br> Procedure: Esophageal Impedance Monitoring (EIM)<br> <br> |
| Control<br>CC/GER- presence of chronic cough and absence of GER by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM) | Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy<br> <br> Procedure: Esophageal Impedance Monitoring (EIM)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group |  | 2 Years | 
| Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group |  | 2 Years |