Gut Microbiota in Chronic Noncommunicable Diseases

Completed

• Conditions: Atherosclerosis Occlusive Disease; Arterial Hypertension; Heart Failure With Preserved Ejection Fraction; Nonalcoholic Fatty Liver Disease; Obstructive Pulmonary Disease; Heart Failure With Reduced Ejection Fraction; Diabetes Mellitus, Type 2; Asthma

• Registration Number: NCT04820556
• Lead Sponsor: National Medical Research Center for Therapy and Preventive Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-04-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1084

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthcare of the Russian Federation; 🇷🇺 Moscow, Russian Federation

Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency; 🇷🇺 Moscow, Russian Federation