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Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients

Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients - Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033020
Enrollment
76
Registered
2018-07-01
Start date
2018-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Interventions

1 packet of Yakult Super Synbiotics as probiotics and 6.8g of Oligosaccharide as prebiotics three times a day for four weeks. Yakult Super Synbiotics contains Lactobacillus casei strain Shirt and Bif

Sponsors

ShonanKamakura General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with CKD stage 5 (eGFR <15 mL/min/1.73 m2) 2)Patients scheduled to undergo dialysis within about 3 months 3)More than 20 years old, either sex 4) Patients who are able to provide informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who received antibacterial treatment by oral or intravenous administration within 1 week before the introduction of dialysis 2) Patients who ingested the study drug of this study or similar substances within 1 week before the introduction of dialysis 3) Patients who received or ingested lactic acid bacteria-containing preparations or oligosaccharide preparations manufactured by Yakult Co., Ltd. within 2 weeks before the introduction of dialysis. 4) Patients who used an intestinal regulator or an oral medical spherical adsorption charcoal within 2 weeks before the introduction of dialysis 5) Patients taking immunosuppressive agents within 6 months before the introduction of dialysis 6) Patients with acute renal failure 7) Patients who have had a kidney transplant before 8) Patients with irritable bowel syndrome, Crohn's disease, ulcerative colitis 9) Patients who have been allergic to milk 10) Pregnant or potentially pregnant women 11) Breastfeeding women 12) Patients who received another study drug or study drug within 3 months before the start of administration of the study drug

Design outcomes

Primary

MeasureTime frame
The variation in blood concentrations of p-cresol is measured before initiation of dialysis and four weeks after initiation. Participants are randomized to symbiotic intake or no treatment. After four weeks intervention, the changes in blood P cresol values are compared.

Countries

Japan

Contacts

Public ContactMasahiro Hirata

ShonanKamakura General Hospital Clinical Research Division, Support Office

m_hirata@shonankamakura.or.jp0467-46-1717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026