Skip to main content
OpenTrials
Completed

NCT Number: NCT02797756

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Cough (CC) Chronic Cough Cough Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux (GER) Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophago-gastro-duodenoscopy (EGD) with biopsy

Procedure

Esophageal Impedance Monitoring (EIM)

Procedure

Primary outcomes

  1. Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group

    Time frame: 2 Years

  2. Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.