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临床试验/NCT03310164
NCT03310164已完成不适用

The Relationship Between Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Microbiota that can predict the progress of lung function

研究概览

简要总结

Increasing evidence have implied that microbiota from airway and gut might be involved in the pathogenesis of chronic obstructive pulmonary disease (COPD). However, the cross-talk between respiratory and gastrointestinal microbiome in COPD is still undetermined. The study is aimed to investigate the interaction between lung and gut flora, and their role in the process of COPD.

详细描述

Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. Cigarette smoking is the principal cause of COPD, but only approximately 15% of adults with substantial tobacco exposure develop clinical COPD. Besides, bacterial colonization or infection is also considered as an important factor in COPD. There are very limited data from microbiome studies that suggest that respiratory and gastrointestinal microbiota may be involved in the pathogenesis of COPD. However, the cross-talk between between lung and gut microbiome, and their relationship with various clinical phenotypes of COPD. Here, we conducted 16S rRNA-based pyrosequencing to evaluate the link between the lung-gut axis and the clinical phenotypes of COPD, such as lung function, emphysema, symptoms, exacerbations, inflammation levels and metabolic features.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • males aged 40-80;
  • diagnosed with COPD according to the GOLD guidelines;
  • clinically stable patients without medication changes or exacerbation in two months;
  • smoking history of more than 10 pack years

排除标准

  • diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence;
  • diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of COPD or pneumonia in two months;
  • prescribed immunosuppressive medications.

结局指标

主要结局

Microbiota that can predict the progress of lung function

时间窗: 6 months

The study is aimed to investigate the relationship between the microbiota and the progress of lung function in COPD

次要结局

  • Bacteria related to metabolomics(6 months)
  • Bacteria related to inflammatory factors(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bei He

Professor and Chief in Department of Respiratory Medicine

Peking University Third Hospital

研究点 (1)

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