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

Study Overview
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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.

Official Title
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Department of Nutrition, China Medical University

Conditions
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Depression Mild, Cardiovascular Diseases

Intervention / Treatment
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* Drug: MIYAIRI 588


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Drug: MIYAIRI 588<br>* In the 3 months intervention, each subjects take 1g/package with meal, and 3 packages/day.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of depression score | Beck Depression Inventory score (Chinese version 2.0). The score range is from 0 to 63, and the higher scores mean a worse outcome. | Change from Baseline depression score at 3 months |