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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Depression Mild Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

MIYAIRI 588

Intervention Type DRUG

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MIYAIRI 588

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No