Chronic Respiratory DiseasesMicrObAsNCT04802317
Intestinal Microbiota in COPD and Asthma
An observational study of Chronic Respiratory Diseases, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
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). Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Respiratory Diseases
- What is being tested?
- Identification of the composition of the intestinal microbiota
- How many people
- 149 participants
- Where
- 1 siteRussia
- Study dates
- 23 Jun 2020to 5 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients without COPD, asthma, chronic bronchitis and other lung diseases for control group. Patients asthma/COPD with for asthma/COPD groups.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.);
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Conditions
- Chronic Respiratory Diseases
- Being tested
- Identification of the composition of the intestinal microbiota
- Keywords
- intestinal microbiota, COPD, asthma, lipopolysaccharides, trimethylamine-N-oxide, course of the diseases, exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of the composition of the intestinal microbiotaDiagnostic test
Identification of the composition of the intestinal microbiota
| Study group | Role | What they receive |
|---|---|---|
| Control | Health people without any respiratory diseases Receives: Diagnostic Test: Identification of the composition of the intestinal microbiota | |
| Bronchial asthma | Patients with asthma Receives: Diagnostic Test: Identification of the composition of the intestinal microbiota | |
| COPD | Patients with chronic obstructive pulmonary disease Receives: Diagnostic Test: Identification of the composition of the intestinal microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start23 Jun 2020
- Primary completion30 Jun 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Center for Strategic Planning and Management of Biomedical Health Risks
- Responsible party
- Sponsor
- Investigators
- Marina Smirnova, PhD, MD, Principal investigator, NRCPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802317
- Sponsor's protocol ID
- 03-08/20
- Acronym
- MicrObAs
- Status last verified
- Dec 2023
- First submitted
- 12 Mar 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04802317
- Acronym / sponsor ID
- MicrObAs / 03-08/20
- Conditions
- Chronic Respiratory Diseases
- Keywords
- intestinal microbiota, COPD, asthma, lipopolysaccharides, trimethylamine-N-oxide, course of the diseases, exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Collaborators
- Center for Strategic Planning and Management of Biomedical Health Risks
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Identification of the composition of the intestinal microbiotaHealth people without any respiratory diseases |
| Bronchial asthma | – | Diagnostic Test: Identification of the composition of the intestinal microbiotaPatients with asthma |
| COPD | – | Diagnostic Test: Identification of the composition of the intestinal microbiotaPatients with chronic obstructive pulmonary disease |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without COPD, asthma, chronic bronchitis and other lung diseases for control group. Patients asthma/COPD with for asthma/COPD groups.
Key inclusion criteria (9 listed)
- Normal spirometry results with bronchodilation test (salbutamol 400 mcg);
- Absence of COPD, asthma, chronic bronchitis and other lung diseases
- BMI<40kg/m2
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of the composition of the intestinal microbiotaIdentification of the composition of the intestinal microbiota | Diagnostic test | Bronchial asthma, COPD, Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
Related trials for Chronic Respiratory Diseases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
TAKINGCARE - TAcKlING the Needs of Carers of People With Chronic respirAtoRy disEases
Chronic Respiratory Disease
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Smirnova, PhD, MD principal investigator
NRCPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Diseases, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation of asthma / chronic obstructive pulmonary disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023; AzTrials last refreshed its copy on 29 Oct 2026.