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Clinical Trials/NCT02797756
NCT02797756
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country35 target enrollmentAugust 5, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Cough (CC)
Sponsor
NYU Langone Health
Enrollment
35
Locations
1
Primary Endpoint
Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 5, 2014
End Date
December 12, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 2 Years

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

Time Frame: 2 Years

Study Sites (1)

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