Intestinal Microbiota in COPD and Asthma
- Conditions
- Chronic Respiratory Diseases
- Registration Number
- NCT04802317
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exacerbation of asthma / chronic obstructive pulmonary disease 12 months Number of patients with exacerbation of bronchial asthma or chronic obstructive pulmonary disease, number of exacerbation per year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NRCPM
🇷🇺Moscow, Russian Federation
NRCPM🇷🇺Moscow, Russian Federation