Evaluating the lung microbiome in patients with NTM bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.