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临床试验/NCT03562442
NCT03562442已完成不适用

Leibniz Association Senate Board of Competition (SAW) Lung Microbiome Study

Research Center Borstel2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change in microbiome pattern in smokers after smoking cessation

研究概览

简要总结

The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.

详细描述

The trial aims to analyze changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in healthy (and willing to quit) smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.

Demographic and clinical data of the study subjects are obtained, aiming for homogeneous groups. All personal data are encrypted according to the standard operating procedures of the study site. Pharyngeal and deep nasal swabs are taken.

To avoid contamination of the lower airways from the oropharynx through the bronchoscope, standardized procedures are established according to the German guidelines for bronchoscopy. Before bronchoscopy, the endoscope is flushed with sterile saline which is analyzed for 16S ribosomal RNA (rRNA) to control for residual contaminating bacterial desoxyribonucleic acid (DNA). A 300ml bronchoalveolar lavage with warm normal saline solution is taken from the middle lobe. Three covered and "microbiologically protected" bronchial brushings are obtained from the right upper lobe. This sterile brush is sealed in wax and pushed through the wax just before taking the brushing. All samples are immediately frozen and stored at -80°C until further analyses. For cultivations, samples are kept at 4°C and rapidly processed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cigarette consumption of at least five cigarettes per day
  • Caucasian ethnicity

排除标准

  • Continous passive smoking exposure
  • Systemic steroid therapy during the previous month
  • Chronic lung disease (exception COPD stage Global Initiative on Lung Disease (GOLD) 0/I/II)
  • Diabetes mellitus
  • Pregnancy or breast feeding
  • active tuberculosis (currently or previously)
  • respiratory infection in the previous month
  • antibiotic therapy in the previous two months
  • immunosuppression
  • malignancy
  • interstitial lung disease
  • rheumatic disease with lung manifestation
  • member of a collaborative group of the project

结局指标

主要结局

Change in microbiome pattern in smokers after smoking cessation

时间窗: 6 Weeks

Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture

次要结局

  • Smoking cessation rates(6 months)
  • Lung microbiome in never-smokers(0 days)

研究者

发起方
Research Center Borstel
申办方类型
Other
责任方
Sponsor

研究点 (2)

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