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

NCT02797756 | Completed

• 1 other identifier: 14-01021
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Cough (CC); Gastroesophageal Reflux (GER)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Case

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

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

Control

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

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

Interventions

Esophago-gastro-duodenoscopy (EGD) with biopsy PROCEDURE

Case; Control

Esophageal Impedance Monitoring (EIM) PROCEDURE

Case; Control

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Chronic Cough; Gastroesophageal Reflux

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mikhail N Kazachkov, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: August 5, 2014
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (1)