Evaluation Of The Pan-microbiome and Host Immune Response in CF
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/16/2018 |
| Start Date: | December 2014 |
| End Date: | November 2023 |
| Contact: | Kathryn Norris |
| Email: | Kathryn.Norris@nyumc.org |
Evaluation Of The Pan-microbiome and Host Immune Response in Cystic Fibrosis (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.
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.
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)
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Leopoldo Segal, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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