Evaluating the lung microbiome in patients with NTM bronchiectasis
Evaluation Of The Lung Microbiome In NTM Bronchiectasis
This study is trying to see how changes in the lung bacteria of people with non-tuberculous mycobacterial disease might be linked to their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02779478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between airway microbiota alterations and pulmonary non-tuberculous mycobacteria (NTM) disease. It will involve a cohort of 200 subjects suspected of having pulmonary NTM disease, where researchers will analyze induced sputum and upper airway samples to assess the microbiome. A subgroup of patients will undergo bronchoscopy to evaluate the microbiome in both upper and lower airways, providing a comprehensive understanding of the microbial landscape associated with NTM. The study seeks to identify specific biomarkers that could be linked to the disease.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of pulmonary symptoms and imaging abnormalities indicative of NTM disease.
Not a fit: Patients who have recently used oral antibiotics or steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with NTM bronchiectasis.
How similar studies have performed: Other studies have explored the lung microbiome in respiratory diseases, suggesting potential for success in this area, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of pulmonary symptoms: cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort * Imaging abnormalities (within 2 years): defined as nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis or bronchial wall thickening with associated multiple small nodules. Definition of NTM case: * Subjects that meet inclusion criteria and have culture positivity for NTM: at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage (BAL) or lung biopsy Definition of NTM control: * Subjects that meet inclusion criteria and have less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage (BAL) or lung biopsy. Exclusion Criteria for cohort study (Aim 1-2): * Recent (\<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable \>1 month prior) * Recent smoking history Exclusion Criteria for bronchoscopic study (Aims 3-4): * Forced expiratory volume at one second (FEV1) \< 70%of predicted. * Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure. * Diabetes mellitus * Significant liver or renal disease * Severe coagulopathy (INR \> 1.4, Partial Thromboplastin Time (PTT) \> 40 seconds and platelet count \< 150x103 cells). * Pregnancy * Ethanol (ETOH) use of more than \>6 beers or \>4 mixed drinks daily * Lack of capacity to provide informed consent.
Where this trial is running
New York, New York
- New York University School of Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Leopoldo Segal, MD — New York University Medical School
- Study coordinator: Lisa Guiterrez
- Email: Lira.Gutierrez@nyulangone.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.