Intestinal Microbiota in COPD and Asthma

Chronic Respiratory Diseases Clinical Trial

— MicrObAs  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802317
• Other study ID #: 03-08/20
• Status: Completed
• Start date: June 23, 2020
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 5, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Respiratory Diseases
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Diagnostic Test:
• Identification of the composition of the intestinal microbiota
Identification of the composition of the intestinal microbiota

Locations

Country	Name	City	State
Russian Federation	NRCPM	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
National Medical Research Center for Therapy and Preventive Medicine	Center for Strategic Planning and Management of Biomedical Health Risks

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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