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临床试验/NCT04490447
NCT04490447Unknown不适用

Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population and Role of the "Gut-lung Axis" in Chronic Respiratory Infection With Pseudomonas Aeruginosa.

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Gut microbiome and metabolomics of bronchiectasis patients and healthy control.

研究概览

简要总结

This study aims to investigate the characteristics of gut microbiome and metabolome in non-CF bronchiectasis patients, hoping to explore the underlying mechanisms as well as the influence of gut microbiota composition on bronchiectasis.

详细描述

Non-cystic fibrosis bronchiectasis is a chronic airway disease characterized by irreversible and progressive dilation of the large airways, bronchi and bronchioles, which severely impairs the life quality of patients and increases the social and economic burden. It is also a heterogenous disease affected by multiple factors such as geography and ethnicity. The incidence of bronchiectasis among the Chinese population is about 1.2%, which has clearly been underestimated. However, due to the lack of awareness, the research of bronchiectasis in China is still in its infancy. Colonization and recurrent infection of pathogen is the primary unsolved problem in clinical practice. With the proposition of "gut-lung axis" theory, the role of gut microbiota in the pathogenesis of respiratory diseases has been gradually revealed. Evidences have shown that gut microbiota regulates respiratory immunity via releasing soluble bacterial components and its metabolites into the circulation, as well as facilitating the migration of immune cells directly to the lung. In the 1980s, a patient after a colectomy has been reported to generate bronchiectasis. The most common clinical manifestation of pulmonary involved IBD patients is also bronchiectasis, suggesting that the "gut-lung axis" may be involved in the pathogenesis of bronchiectasis. Therefore, clarifying the role and mechanism of gut microbiota in bronchiectasis and its gut microbiome is expected to provide new theoretical basis and ideas for its diagnosis and treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Written informed consent
  • •Regular bowel movement: every 2 days - 3 times/ day
  • •The diagnose of bronchiectasis should refer to "BTS guideline 2010"

排除标准

  • •Diagnosis of ABPA
  • •Pregnancy or lactation
  • •Active smoking or alcohol using within last 6 months
  • •HIV infection
  • •Previous abdominal or rectal surgery
  • •Diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal insufficiency (GFR < 30ml/min) or immunodeficiency
  • •Regular use of the following types of medications (> 2 times per week) within last 2 months: opium, loperamide antidiarrheal, systemic antihistaminic, metoclopramide, proton pump inhibitor
  • •Poor compliance or inability to cooperate as judged by the doctor

结局指标

主要结局

Gut microbiome and metabolomics of bronchiectasis patients and healthy control.

时间窗: 12 months

The microbiome and metabolome results of gut in bronchiectasis patients will be defined from the stool samples using 16S rRNA Miseq sequencing and nontargeted LC-MS-based metabolomics approach.

次要结局

  • Lung microbiome of bronchiectasis patient.(12 months)
  • BSI (Bronchiectasis Severity Index) score(2 months)
  • Lung function(12 months)
  • Sputum bacteriological evaluation.(12 months)
  • Chest high-resolution computed tomography (CT).(12 months)
  • Acute exacerbation(12 months)
  • Hospitalization(12 months)
  • Duration to the first exacerbation during the one-year follow up.(24 months)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Fu Xu

Director, Head of respiratory medicine

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

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