Actively Recruiting
Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Led by NYU Langone Health · Updated on 2026-02-27
1000
Participants Needed
1
Research Sites
873 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.
CONDITIONS
Official Title
Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of pulmonary symptoms such as cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort
- Imaging abnormalities within 2 years showing nodular or cavitary opacities on chest radiograph or CT scan indicating bronchiectasis or bronchial wall thickening with multiple small nodules
- For NTM cases: positive culture for NTM from at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage or lung biopsy
- For NTM controls: less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage or lung biopsy
- Ability to provide informed consent
You will not qualify if you...
- Oral antibiotic or steroid use within the past 1 month (except continuous macrolides and inhaled steroids if used more than 1 month prior)
- Recent smoking history
- Forced expiratory volume in one second (FEV1) less than 70% predicted (for bronchoscopic study subgroup)
- Significant cardiovascular disease such as abnormal EKG, suspected or known coronary artery disease, or congestive heart failure
- Diabetes mellitus
- Significant liver or kidney disease
- Severe coagulopathy (INR > 1.4, PTT > 40 seconds, platelet count < 150x10^3 cells)
- Pregnancy
- Excessive alcohol use defined as more than 6 beers or 4 mixed drinks daily
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
New York University School of Medicine
New York, New York, United States, 10016
Actively Recruiting
Research Team
L
Lisa Guiterrez
CONTACT
R
Rosemary Schluger
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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