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

Primary Purpose

Depression Mild, Cardiovascular Diseases

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
MIYAIRI 588
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression Mild

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
September 21, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05724511
Brief Title
The Effect of Probiotics on Depression Syndrome and Risk Factors of Cardiovascular Disease in Hemodialysis Patients
Official Title
Department of Nutrition, China Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Cardiovascular Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
MIYAIRI 588
Intervention Description
In the 3 months intervention, each subjects take 1g/package with meal, and 3 packages/day.
Primary Outcome Measure Information:
Title
The change of depression score
Description
Beck Depression Inventory score (Chinese version 2.0). The score range is from 0 to 63, and the higher scores mean a worse outcome.
Time Frame
Change from Baseline depression score at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404327
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have promised our subjects that all of their information will be protected, and this is included in the Informed Consent Form.

Learn more about this trial

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

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