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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02797756

Enrollment

Registered

2016-06-13

Start date

2014-08-05

Completion date

2018-12-12

Last updated

2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cough (CC), Gastroesophageal Reflux (GER)

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).

Interventions

PROCEDUREEsophago-gastro-duodenoscopy (EGD) with biopsy

PROCEDUREEsophageal Impedance Monitoring (EIM)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Years

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026