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

Completed

• Conditions: Chronic Cough (CC); Gastroesophageal Reflux (GER)
• Interventions: Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy; Procedure: Esophageal Impedance Monitoring (EIM)

• Registration Number: NCT02797756
• Lead Sponsor: NYU Langone Health

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-05
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-13
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Esophageal Impedance Monitoring (EIM)	CC/GER- presence of chronic cough and absence of GER by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)
Case	Esophago-gastro-duodenoscopy (EGD) with biopsy	CC/GER+ presence of chronic cough and presence of GER evidenced by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)
Control	Esophago-gastro-duodenoscopy (EGD) with biopsy	CC/GER- presence of chronic cough and absence of GER by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)
Case	Esophageal Impedance Monitoring (EIM)	CC/GER+ presence of chronic cough and presence of GER evidenced by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States