CompletedNot Applicable

Gut Microbiota in Chronic Noncommunicable Diseases

Russia1,084 participantsStarted 2021-04-12

Plain-language 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.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: on enrollment

Trial details

NCT IDNCT04820556

SponsorNational Medical Research Center for Therapy and Preventive Medicine

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Arterial Hypertension trials

Plain-language summary

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Gut Microbiota in Chronic Noncommunicable Diseases

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Gut Microbiota in Chronic Noncommunicable Diseases

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria