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

Phase 4

Completed

• Conditions: Cardiovascular Diseases; Depression Mild
• Interventions: Drug: MIYAIRI 588

• Registration Number: NCT05724511
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-13
• Study Start: 2023-02-27
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	MIYAIRI 588	-

Primary Outcome Measures

Name	Time	Method
The change of depression score	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.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan