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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-05

Study Completion Date

2018-12-12

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).

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Detailed Description

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Conditions

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Chronic Cough (CC) Gastroesophageal Reflux (GER)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

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

Esophago-gastro-duodenoscopy (EGD) with biopsy

Intervention Type PROCEDURE

Esophageal Impedance Monitoring (EIM)

Intervention Type PROCEDURE

Control

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

Esophago-gastro-duodenoscopy (EGD) with biopsy

Intervention Type PROCEDURE

Esophageal Impedance Monitoring (EIM)

Intervention Type PROCEDURE

Interventions

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Esophago-gastro-duodenoscopy (EGD) with biopsy

Intervention Type PROCEDURE

Esophageal Impedance Monitoring (EIM)

Intervention Type PROCEDURE

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

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No