Evaluation Of The Pan-microbiome and Host Immune Response in CF

Evaluation Of The Pan-microbiome and Host Immune Response in Cystic Fibrosis (CF)

Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses.

While chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis (CF)
• Intervention / Treatment: Procedure: Two-Bronchoscope Technique

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Multicenter study to create a longitudinal cohort of adult CF subjects recruited from NYU and Columbia. A subgroup of subjects will be selected for a more invasive assessment of the lung microbiome with research bronchoscopy.

Description

Inclusion Criteria:

• CF diagnosis
• able to produce sputum
• no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days
• FEV1 ≥ 30% of predicted.

Exclusion Criteria:

• Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment
• introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment
• use of new investigational therapy within 4 weeks
• current smoker; use of oral corticosteroids
• Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.
• liver enzymes > 3 times the upper limit
• pregnancy

Additional Exclusion Criteria for Bronchoscopy Subgroup (Aims 2 and 3):

• FEV1 < 50% of predicted.
• Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
• Significant renal disease (Creatinine Clearance < 30%).
• Severe malnutrition (BMI <18kg/m2)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stable Group	Procedure: Two-Bronchoscope Technique; Used to validate the use of sputum to sample the lower airway microbiome
Rapid Decliner Group	Procedure: Two-Bronchoscope Technique; Used to validate the use of sputum to sample the lower airway microbiome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Oral Inflammatory markers	Baseline, 6 Months
Changes in Sputum Inflammatory Markers measured using research bronchoscopy	Baseline, 6 Months
Changes in Gut Microbiome	Baseline, 6 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Leopoldo Segal, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2015
• Primary Completion (Actual): June 16, 2017
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimated): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cystic Fibrosis (CF)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 14-01692

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No