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

Cardiovascular Diseases Clinical Trial

Official title:

Department of Nutrition, China Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05724511
• Other study ID #: CMUH111-REC3-178
• Status: Completed
• Phase: Phase 4
• Start date: February 27, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Depression Mild
• Depressive Disorder

Intervention

Drug:
• MIYAIRI 588
In the 3 months intervention, each subjects take 1g/package with meal, and 3 packages/day.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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