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

NCT05724511 | Completed Phase 4

• 1 other identifier: CMUH111-REC3-178
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Mild; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Drug: MIYAIRI 588

Control

NO INTERVENTION

Interventions

MIYAIRI 588 DRUG

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

Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Assistant Professor

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: February 27, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)