- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04802317
Intestinal Microbiota in COPD and Asthma (MicrObAs)
December 5, 2023 updated by: National Medical Research Center for Therapy and Preventive Medicine
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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Moscow, Russian Federation, 101000
- NRCPM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Health people without any respiratory diseases
|
Identification of the composition of the intestinal microbiota
|
Bronchial asthma
Patients with asthma
|
Identification of the composition of the intestinal microbiota
|
COPD
Patients with chronic obstructive pulmonary disease
|
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
Time Frame: 12 months
|
Number of patients with exacerbation of bronchial asthma or chronic obstructive pulmonary disease, number of exacerbation per year
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marina Smirnova, PhD, MD, NRCPM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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