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Clinical Trials/NCT04820556
NCT04820556
Completed
Not Applicable

The Development of Preventive Methods for Chronic Noncommunicable Diseases Based on Modulation of Gut Microbiota Composition and Function

National Medical Research Center for Therapy and Preventive Medicine2 sites in 1 country1,084 target enrollmentApril 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arterial Hypertension
Sponsor
National Medical Research Center for Therapy and Preventive Medicine
Enrollment
1084
Locations
2
Primary Endpoint
Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
December 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anastasia Kaburova

junior researcher

National Medical Research Center for Therapy and Preventive Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide

Time Frame: on enrollment

Study Sites (2)

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