Intestinal Microbiota in COPD and Asthma (MicrObAs)

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)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

• Study Contact: Name: Marina Smirnova, PhD, MD; Phone Number: +79161168325; Email: MSmirnova@gnicpm.ru
• Study Contact Backup: Name: Yana Koshelyaevskaya, MSc; Phone Number: +79153324504; Email: YKoshelyaevskaya@gnicpm.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 101000
    • NRCPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients without COPD, asthma, chronic bronchitis and other lung diseases for control group. Patients asthma/COPD with for asthma/COPD groups.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Medical Research Center for Therapy and Preventive Medicine
• Collaborators: Center for Strategic Planning and Management of Biomedical Health Risks
• Investigators: Principal Investigator: Marina Smirnova, PhD, MD, NRCPM

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COPD; exacerbation; asthma; intestinal microbiota; lipopolysaccharides; trimethylamine-N-oxide; course of the diseases
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 03-08/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No