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NCT05724511
The Effect of Probiotics on Depression Syndrome and Risk Factors of Cardiovascular Disease in Hemodialysis Patients
Phase 4 trial testing MIYAIRI 588 in Depression Mild in 55 participants. Completed in 31 July 2023.
30 June 2023
Quick facts
| Lead sponsor | China Medical University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 55 |
| Start date | 27 February 2023 |
| Primary completion | 30 June 2023 |
| Estimated completion | 31 July 2023 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- MIYAIRI 588 — full drug profile →
Conditions studied
- Depression Mild — all drugs for Depression Mild →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
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):
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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:
- PubMed search for NCT05724511
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other China Medical University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05724511 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China Medical University Hospital
- Last refreshed: 22 September 2023
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.
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