Evaluation Of The Pan-microbiome and Host Immune Response in Cystic Fibrosis (CF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Gut Microbiome
研究概览
简要总结
Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses.
While chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CF diagnosis
- •able to produce sputum
- •no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days
- •FEV1 ≥ 30% of predicted.
排除标准
- •Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment
- •introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment
- •use of new investigational therapy within 4 weeks
- •current smoker; use of oral corticosteroids
- •Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.
- •liver enzymes > 3 times the upper limit
- •pregnancy
- •Additional Exclusion Criteria for Bronchoscopy Subgroup (Aims 2 and 3):
- •FEV1 < 50% of predicted.
- •Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
- •Significant renal disease (Creatinine Clearance < 30%).
- •Severe malnutrition (BMI <18kg/m2)
结局指标
主要结局
Changes in Gut Microbiome
时间窗: Baseline, 6 Months
Changes in Sputum Inflammatory Markers measured using research bronchoscopy
时间窗: Baseline, 6 Months
Changes in Oral Inflammatory markers
时间窗: Baseline, 6 Months
次要结局
未报告次要终点
