NCT05724511

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

Department of Nutrition, China Medical University

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression Mild
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	MIYAIRI 588	In the 3 months intervention, each subjects take 1g/package with meal, and 3 packages/day.

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-06-30
• Completion: 2023-07-31
• First posted: 2023-02-13
• Last updated: 2023-09-22

Locations

1 site across 1 country: Taiwan