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Intestinal Microbiota in COPD and Asthma

NCT ID: NCT04802317

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-23

Study Completion Date

2023-12-05

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.

Conditions

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Chronic Respiratory Diseases

Keywords

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intestinal microbiota COPD asthma lipopolysaccharides trimethylamine-N-oxide course of the diseases exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Health people without any respiratory diseases

Identification of the composition of the intestinal microbiota

Intervention Type DIAGNOSTIC_TEST

Identification of the composition of the intestinal microbiota

Bronchial asthma

Patients with asthma

Identification of the composition of the intestinal microbiota

Intervention Type DIAGNOSTIC_TEST

Identification of the composition of the intestinal microbiota

COPD

Patients with chronic obstructive pulmonary disease

Identification of the composition of the intestinal microbiota

Intervention Type DIAGNOSTIC_TEST

Identification of the composition of the intestinal microbiota

Interventions

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Identification of the composition of the intestinal microbiota

Identification of the composition of the intestinal microbiota

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Strategic Planning and Management of Biomedical Health Risks

UNKNOWN

Sponsor Role collaborator

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marina Smirnova, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

NRCPM

Locations

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NRCPM

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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03-08/20

Identifier Type: -

Identifier Source: org_study_id