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NOT YET RECRUITING
NCT07443280
NA

Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic

Sponsor: Tungs' Taichung Metroharbour Hospital

View on ClinicalTrials.gov

Summary

Patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis frequently exhibit significant gut microbiota dysbiosis and increased intestinal permeability. These alterations enable the translocation of endotoxins and gut-derived uremic toxins-such as indoxyl sulfate and p-cresyl sulfate-into the systemic circulation, exacerbating systemic inflammation, elevating cardiovascular risk, and accelerating disease progression. Multispecies synbiotic supplementation has emerged as a promising intervention to restore gut microbial equilibrium, strengthen intestinal barrier function, and reduce the systemic load of harmful microbial metabolites. Through modulation of inflammatory pathways and reduction of circulating uremic toxins, synbiotic hold potential to improve clinical outcomes in this vulnerable population. Although preclinical and some clinical evidence suggests benefits of probiotic therapy, comprehensive clinical trials specifically examining multispecies synbiotic effects on gut inflammatory markers, gut derived metabolite profiles, and uremic toxin levels in hemodialysis patients remain limited. This pilot study aims to address this gap by investigating the biological and clinical effects of a 12-week multispecies regimen in adult maintenance hemodialysis patients.

Official title: Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic Supplementation in Hemodialysis Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2026-12-31

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Multispecies Synbiotic Supplementation

Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. * Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. * Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.

Locations (1)

Tungs' Taichung Metroharbour Hospital

Taichung, Wuqi District, Taiwan