The Effect of Probiotics on Depression Syndrome and Risk Factors of Cardiovascular Disease in Hemodialysis Patients

As the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients. Besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population. Both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients. Therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients. This is a randomized controlled trial. All patients will be assigned at random to intervention group or control group. This study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period. The investigators provide probiotics (C. butyricum MIYAIRI 588) to intervention group and provide nothing to the control group.

All patients need to maintain the lifestyle during study period. Genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.

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Key information

Conditions

Depression Mild Cardiovascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China Medical University Hospital

Taichung, 404327, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 20 years or older undergoing hemodialysis (at least 3 months), 3 times per week, and URR ≥65%

Exclusion criteria

allergic to the components of the intervention drug, low tolerance of milk or dairy products
Has the diagnosis of dementia, delirium, bipolar disorder, schizophrenia, or liver failure
Beck Depression Inventory Chinese version 2.0 score higher than 14, or has significant suicide risk during study
Following significantly clinical syndrome: obsessive compulsive disorder, schizoid personality disorder, schizotypal personality, paranoid、antisocial Personality Disorder, histrionic personality disorder
With addiction to alcohol or drugs, terminal cancer, severe infection, heart failure, central venous catheter in the past 6 months
Taking antibiotics, anti-oxidant vitamin supplement, probiotics, prebiotics, antidepressants, anti-anxiety medicine, yogurt and the products in the past 3 months
Pregnant or lactating

Treatment and study plan

MIYAIRI 588

Drug

In the 3 months intervention, each subjects take 1g/package with meal, and 3 packages/day.

Primary outcomes

The change of depression score

Time frame: Change from Baseline depression score at 3 months

Beck Depression Inventory score (Chinese version 2.0). The score range is from 0 to 63, and the higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Department of Nutrition, China Medical University

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 13, 2023
Registry last updated: Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed