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

NCT02778750 | Completed

• 1 other identifier: 14-01692
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Keywords

Cystic Fibrosis (CF)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Stable Group

Procedure: Two-Bronchoscope Technique

Rapid Decliner Group

Procedure: Two-Bronchoscope Technique

Interventions

Two-Bronchoscope Technique PROCEDURE

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

Rapid Decliner Group; Stable Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Leopoldo Segal

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 20, 2016
• Study Start: June 5, 2015
• Primary Completion: June 16, 2017
• Study Completion: March 12, 2020
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

US (1)