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

NYU Langone Health

Status: Completed

Conditions: Gastroesophageal Reflux (GER); Chronic Cough (CC)

Treatments: Procedure: Esophageal Impedance Monitoring (EIM); Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02797756

14-01021

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Ages: Under 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Case

Description:

CC/GER+ presence of chronic cough and presence of GER evidenced by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)

Treatment:

Procedure: Esophageal Impedance Monitoring (EIM)

Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy

Control

Description:

CC/GER- presence of chronic cough and absence of GER by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)

Treatment:

Procedure: Esophageal Impedance Monitoring (EIM)

Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy