MicrObAs: Intestinal Microbiota in COPD and Asthma

Sponsor

National Medical Research Center for Therapy and Preventive Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04802317

Collaborator

Center for Strategic Planning and Management of Biomedical Health Risks (Other)

140

Enrollment

Location

42.3

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Respiratory Diseases	Diagnostic Test: Identification of the composition of the intestinal microbiota

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)

Actual Study Start Date :

Jun 23, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Control Health people without any respiratory diseases	Diagnostic Test: Identification of the composition of the intestinal microbiota Identification of the composition of the intestinal microbiota
Bronchial asthma Patients with asthma	Diagnostic Test: Identification of the composition of the intestinal microbiota Identification of the composition of the intestinal microbiota
COPD Patients with chronic obstructive pulmonary disease	Diagnostic Test: Identification of the composition of the intestinal microbiota Identification of the composition of the intestinal microbiota

Arm

Intervention/Treatment

Control

Health people without any respiratory diseases

Diagnostic Test: Identification of the composition of the intestinal microbiota

Identification of the composition of the intestinal microbiota

Bronchial asthma

Patients with asthma

Diagnostic Test: Identification of the composition of the intestinal microbiota

Identification of the composition of the intestinal microbiota

COPD

Patients with chronic obstructive pulmonary disease

Diagnostic Test: Identification of the composition of the intestinal microbiota

Identification of the composition of the intestinal microbiota

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.