Identifying the Relationship Between the Features of the Composition and Functioning of the Intestinal Microbiota With the Course of Chronic Obstructive Pulmonary Disease and Asthma (MicrObAs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Exacerbation of asthma / chronic obstructive pulmonary disease
研究概览
简要总结
The composition of the intestinal microbiota, the level of lipopolysaccharides, TMAO in the blood, and other parameters of patients with COPD (n=50), asthma (n=50) and the control (n=40) will be assessed as factors associated with exacerbations and respiratory symptoms in the prospective study (12 months).
详细描述
The patients from "Biobank of blood and feces for the development of a clinical and biological platform as a basis for an innovative approach to the prevention of chronic non-infectious diseases based on the composition of the intestinal microbiota" study will be included (cross-sectional study). The protocol of the above study included the assessment of socio-demographic, anthropometric data, clinical blood pressure (BP), ECG, blood tests, fecal microbiota studies, spirometry data, diet questionnaire. ABPM, HBP, other questionnaires (mMRC, CAT, ACQ-5, GMBQ) will be added to initial data (=visit 1). Than the four visits (2-5th visits) in 3 each months will be performed to assess respiratory symptoms, exacerbations of COPD/asthma, respiratory infections, therapy, BP, and other parameters. The standard statistical methods will be used.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for control group:
- •Normal spirometry results with bronchodilation test (salbutamol 400 mcg);
- •Absence of COPD, asthma, chronic bronchitis and other lung diseases
- •BMI<40kg/m2
- •for asthma/COPD groups:
- •Primary medical documentation confirming the diagnosis of COPD or asthma
- •Regular therapy for COPD, asthma and any chronic disease for at least 4 weeks prior to enrollment in this study.
- •FEV1 / FVC <0.70 after inhalation of 400 mcg of salbutamol for patients with COPD
- •BMI<40kg/m2
排除标准
- •Exacerbation of chronic noninfectious diseases, including exacerbation of COPD / asthma, within 4 weeks prior to enrollment in this study.
- •Exacerbation of COPD or asthma in the next 3 months, requiring the treatment of antibiotic therapy or systemic corticosteroids;
- •Cerebral stroke, transient ischemic attack or myocardial infarction within 6 months before the date of enrollment in the study;
- •Clinically significant chronic diseases (oncological, systemic diseases of the connective tissue, diseases of the blood system, heart failure, Crohn's disease, ulcerative colitis, etc. according to anamnesis);
- •GFR <30 ml / min / 1.73m2;
- •Atopy in a patient with COPD or a control group (any allergic manifestations - skin, nasal, conjunctival, food, etc.);
- •Chronic respiratory diseases in a patient of the control group (COPD, asthma, chronic bronchitis, interstitial lung diseases);
- •History of organ transplantation;
- •Mental illness;
- •Intestinal infection (food poisoning) in the next 3 months;
- •Other acute infectious diseases. It is possible to turn on not earlier than 4 weeks after complete recovery and cessation of treatment;
- •History of severe COVID-19;
- •HIV infection, chronic viral hepatitis according to the history;
- •Clinically significant oncological disease;
- •Pregnancy and lactation;
- •Alcoholism, taking narcotic drugs;
- •Taking antimicrobial, probiotic drugs and systemic corticosteroids during the last 3 months;
- •Genetic engineering / biological therapy.
结局指标
主要结局
Exacerbation of asthma / chronic obstructive pulmonary disease
时间窗: 12 months
Number of patients with exacerbation of bronchial asthma or chronic obstructive pulmonary disease, number of exacerbation per year
次要结局
未报告次要终点