Evaluation Of The Lung Microbiome In NTM Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls
时间窗: 4 Hours
Investigators will use sputum samples and brushed samples from areas of the upper airway from a cohort of 200 subjects with chronic cough and pulmonary infiltrates or airway abnormalities in whom NTM disease was suspected. Cultures positive for NTM (cases) will be compared to those with culture negatives (controls). Bacterial load by quantitative polymerase chain reaction (qPCR) will be used to characterize microbiome by high throughput sequencing looking for microbial biomarkers associated with NTM disease.
次要结局
- Eating Assessment Tool (EAT-10) to evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls(1 Hour)
- Reflux Symptom Index evaluate the prevalence of laryngopharyngeal reflux and dysphagia/aspiration in subjects with active pulmonary NTM disease compared with controls(1 Hour)
- Laryngoscopy to calculate the Reflux finding score (RFS, a validated quantitative measurement of impact of laryngopharyngeal reflux on the upper airway in adults(4 Hours)