Actively Recruiting
Evaluation of the Lung Microbiome in Pulmonary Nontuberculous Mycobacteria Bronchiectasis
Led by NYU Langone Health · Updated on 2026-02-27
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether changes in the airway microbiome are linked to pulmonary Non-tuberculous mycobacteria (NTM) disease in people suspected of having this condition. This observational study includes 200 participants and compares those with active NTM infection to those without based on sputum or lung sample cultures. The goal is to better understand the airway bacteria differences in NTM bronchiectasis. Participants will provide induced sputum and upper airway samples to analyze the airway microbiome. A subgroup will also undergo bronchoscopy to collect lower airway samples for comparison. The study groups include individuals with positive NTM cultures and controls with negative cultures. Procedures like bronchoscopy will be used to assess the lung microbiome more directly. During the study, participants will be assessed through airway sample collection and clinical evaluations. Researchers will use tools such as the Eating Assessment Tool (EAT-10), laryngoscopy, and the Reflux Symptom Index to evaluate symptoms related to airway reflux and swallowing difficulties. The primary outcome is to compare the airway microbiome between those with active pulmonary NTM disease and controls. The study includes safety and consent monitoring, with participation lasting according to study schedules.
CONDITIONS
Brief Title
Evaluation Of The Lung Microbiome In NTM Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- History of pulmonary symptoms such as cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort
- Chest imaging abnormalities within the last 2 years showing nodular or cavitary opacities, 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 one bronchoalveolar lavage (BAL) or lung biopsy
- For NTM controls: less than two separate expectorated induced sputum samples culture-negative or culture-negative BAL or lung biopsy
You will not qualify if you...
- Oral antibiotic or steroid use within 1 month prior to study entry (except continuous macrolides and inhaled steroids if stopped over 1 month prior)
- Recent smoking history
- Forced expiratory volume in one second (FEV1) less than 70% of predicted (for bronchoscopic subgroup)
- Significant cardiovascular disease including abnormal EKG, coronary artery disease, or congestive heart failure
- Diabetes mellitus
- Significant liver or kidney disease
- Severe coagulopathy (INR > 1.4, PTT > 40 seconds, platelet count < 150,000 cells)
- Pregnancy
- Alcohol use exceeding 6 beers or 4 mixed drinks daily
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Less than 1 day
Participants undergo bronchoscopy and other assessments to evaluate the lung microbiome and related symptoms.
1 visit (in-person)
Duration - Up to several years until study completion
Participants are observed over time to monitor changes in lung microbiome and related respiratory symptoms.
Visits as scheduled depending on study assessments
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
R
Rosemary Schluger
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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