Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Launched by NYU LANGONE HEALTH · May 18, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the lung microbiome, which is the community of tiny microorganisms in our airways, to see how it relates to a condition called Nontuberculous Mycobacteria (NTM) bronchiectasis. The researchers want to understand if changes in the lung microbiome are linked with NTM disease. They will recruit 200 participants who have had symptoms like cough, fatigue, or chest discomfort, and have imaging tests showing issues in their lungs. The study will involve collecting samples from participants’ airways to analyze the microbiome.

To be eligible, participants should have a history of specific pulmonary symptoms and recent imaging that shows abnormalities in their lungs. Those with certain health conditions, recent antibiotic use, or smoking history may not be eligible. If you join the study, you’ll provide samples through simple methods like coughing up sputum or, in some cases, with a bronchoscopy, which involves a small camera to look inside your lungs. The findings could help researchers understand how to better manage and treat NTM bronchiectasis in the future.

Gender

ALL

Eligibility 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.