Status:
COMPLETED
Intestinal Microbiota in COPD and Asthma
Lead Sponsor:
National Medical Research Center for Therapy and Preventive Medicine
Collaborating Sponsors:
Center for Strategic Planning and Management of Biomedical Health Risks
Conditions:
Chronic Respiratory Diseases
Eligibility:
All Genders
18-74 years
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 asses...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 5 2023
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04802317
Start Date
June 23 2020
End Date
December 5 2023
Last Update
December 6 2023
Active Locations (1)
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1
NRCPM
Moscow, Russia, 101000