NCT04802317Completed
Intestinal Microbiota in COPD and Asthma
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)
Source: ClinicalTrials.gov · Last updated 6 Dec 2023
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 149 (actual)
- First submitted
- 12 Mar 2021
- Start date
- 23 Jun 2020
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- NCT number
- NCT04802317
What you commit to
- Study type: Observational
- Participants enrolled: 149
- From 23 Jun 2020 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Alcoholism, taking narcotic drugs;
- Taking antimicrobial, probiotic drugs and systemic corticosteroids during the last 3 months;
- Genetic engineering / biological therapy.
Other illness
- 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);
- 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;
Lab values
- GFR \<30 ml / min / 1.73m2;
Other
- Pregnancy and lactation;
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NRCPM Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.