Last reviewed · How we verify

NCT05724511

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

Completed Phase 4 Last updated 22 September 2023
What this trial tests

Phase 4 trial testing MIYAIRI 588 in Depression Mild in 55 participants. Completed in 31 July 2023.

Timeline
27 February 2023
Primary endpoint
30 June 2023
31 July 2023

Quick facts

Lead sponsorChina Medical University Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment55
Start date27 February 2023
Primary completion30 June 2023
Estimated completion31 July 2023
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

China Medical University Hospital

Who can join

20 and older, any sex, with Depression Mild or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Synbiotics, prebiotics and probiotics for people with chronic kidney disease.
    Cooper TE, Khalid R, Chan S, Craig JC, et al · · 2023 · cited 35× · PMID 37870148 · DOI 10.1002/14651858.cd013631.pub2

Verify or expand the search:

Other trials of MIYAIRI 588

Trials testing the same drug.

Other recruiting trials for Depression Mild

Currently open trials in the same condition.

Other China Medical University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05724511.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing