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

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ClinicalTrials.gov Identifier: NCT02797756
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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).

Condition or disease Intervention/treatment
Chronic Cough (CC) Gastroesophageal Reflux (GER) Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy Procedure: Esophageal Impedance Monitoring (EIM)

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough GERD

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  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 ]

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)


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Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797756


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Mikhail N Kazachkov, MD New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02797756     History of Changes
Other Study ID Numbers: 14-01021
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Cough
Inflammation
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms