Gut Microbiota in Chronic Noncommunicable Diseases
The Development of Preventive Methods for Chronic Noncommunicable Diseases Based on Modulation of Gut Microbiota Composition and Function
1 other identifier
observational
1,084
1 country
2
Brief Summary
It is an observational study in patients with chronic noncommunicable diseases (i.e. cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease and asthma ) and control group with no signs of these conditions. The study has a prospective part planned for 2021 and a retrospective part which includes the patients enrolled between 2018-2020. The aim of the study is to investigate gut microbiota composition, its metabolites, levels of inflammatory and other markers of the disease in prospective groups (arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease and control patients) as well as in retrospective groups (chronic heart failure with preserved and reduced ejection fraction, obstructive atherosclerosis of any vascular bed, arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease, and control patients). Also we are planning to investigate the association between gut microbiota composition and its metabolites, levels of inflammatory and other markers of the disease in retrospective and prospective groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedApril 19, 2022
April 1, 2022
8 months
March 25, 2021
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide
on enrollment
Study Arms (8)
Arterial hypertension
Atherosclerosis occlusive disease
Heart failure with preserved ejection fraction
Heart failure with reduced ejection fraction
Diabetes mellitus, type 2
Chronic obstructive pulmonary disease and asthma
Nonalcoholic fatty liver disease
Control group
Eligibility Criteria
Patients with chronic noncommunicable diseases including cardiovascular diseases, type 2 diabetes mellitus, nonalcoholic fatty liver disease, chronic obstructive pulmonary disease, asthma and control group
You may qualify if:
- All mentioned groups:
- Men and women aged ≥ 18 and \<80
- Signed informed consent form
- No current treatment of hypertension
- Systolic blood pressure \<180 mm Hg and diastolic blood pressure \<110 mm Hg
- No clinical signs of other cardiovascular diseases
- Medical records, confirming COPD or asthma
- Regular stable treatment of COPD, asthma or any chronic disease for ≥ 4 weeks before the enrollment. If inhaled corticosteroids are being used, regular treatment is required for ≥12 weeks.
- Absence of acute exacerbations of COPD, asthma or any concomitant diseases 4 weeks before the enrollment
- No use of genetically engineered biological drugs
- For patients with COPD after inhalation of salbutamol (400 mcg) the ratio FEV1/FVC is less than 0,70
- Confirmed type 2 diabetes mellitus
- Stable glucose lowering treatment for ≥ 1 month
- No systemic corticosteroid treatment 4 weeks before the enrollment
- Ultrasound criteria of non-alcoholic fatty liver disease or
- +5 more criteria
You may not qualify if:
- Age \< 18 years and ≥80 years
- Denial of further participation
- Obesity with BMI≥40 kg/m2
- History of organ transplantion
- Psychiatric disorder, limiting participation in the study
- Acute infections
- Exacerbation of chronic infection 2 weeks before the enrollment
- Cancer with no radical treatment
- Pregnancy and lactation
- Alcohol and drug addition
- Chronic kidney disease with GFR \<30 ml/min/1.73m2
- Systemic autoimmune diseases
- Inflammatory bowel disease
- Antimicrobial and probiotic treatment 3 months before the enrollment
- Ischemic heart disease (angina pectoris, myocardial infarction), cerebrovascular disease (stroke, transient ischemic attack), occlusive peripheral arterial disease, revascularization of any vascular bed.
- +59 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthcare of the Russian Federation
Moscow, 101990, Russia
Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency
Moscow, 119121, Russia
Biospecimen
Serum, plasma, stool samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- junior researcher
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
April 12, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
April 19, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share