Intestinal Microbiota in COPD and Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Chronic Respiratory Diseases

Intervention / Treatment
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* Diagnostic Test: Identification of the composition of the intestinal microbiota


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Health people without any respiratory diseases | Diagnostic Test: Identification of the composition of the intestinal microbiota<br>* Identification of the composition of the intestinal microbiota<br>|
| Bronchial asthma<br>Patients with asthma | Diagnostic Test: Identification of the composition of the intestinal microbiota<br>* Identification of the composition of the intestinal microbiota<br>|
| COPD<br>Patients with chronic obstructive pulmonary disease | Diagnostic Test: Identification of the composition of the intestinal microbiota<br>* Identification of the composition of the intestinal microbiota<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation of asthma / chronic obstructive pulmonary disease | Number of patients with exacerbation of bronchial asthma or chronic obstructive pulmonary disease, number of exacerbation per year | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal microbiota, COPD, asthma, lipopolysaccharides, trimethylamine-N-oxide, course of the diseases, exacerbation