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

NCT ID: NCT02778750

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-05
• Study Completion Date: 2020-03-12

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.

Conditions

Cystic Fibrosis (CF)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stable Group

Two-Bronchoscope Technique

Intervention Type: PROCEDURE

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

Rapid Decliner Group

Two-Bronchoscope Technique

Intervention Type: PROCEDURE

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

Interventions

Two-Bronchoscope Technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leopoldo Segal

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

14-01692

Identifier Type: -

Identifier Source: org_study_id