Cystic Fibrosis (CF)
Conditions
Keywords
Cystic Fibrosis (CF)
Brief summary
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.
Interventions
PROCEDURETwo-Bronchoscope Technique
Used to validate the use of sputum to sample the lower airway microbiome
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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 |
Countries
United States
Outcome results
None listed