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

Cystic Fibrosis (CF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778750
• Other study ID #: 14-01692
• Status: Completed
• Start date: June 5, 2015
• Est. completion date: March 12, 2020

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 12, 2020
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis (CF)
• Fibrosis

Intervention

Procedure:
• Two-Bronchoscope Technique
Used to validate the use of sputum to sample the lower airway microbiome

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Oral Inflammatory markers		Baseline, 6 Months
Primary	Changes in Sputum Inflammatory Markers measured using research bronchoscopy		Baseline, 6 Months
Primary	Changes in Gut Microbiome		Baseline, 6 Months