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

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Key information

Conditions

Cystic Fibrosis (CF) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Two-Bronchoscope Technique

Procedure

Used to validate the use of sputum to sample the lower airway microbiome

Primary outcomes

Changes in Oral Inflammatory markers

Time frame: Baseline, 6 Months
Changes in Sputum Inflammatory Markers measured using research bronchoscopy

Time frame: Baseline, 6 Months
Changes in Gut Microbiome

Time frame: Baseline, 6 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2020
First posted: May 20, 2016
Registry last updated: Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed