RecruitingNot ApplicableNCT07443280

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

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


Sponsor

Tungs' Taichung Metroharbour Hospital

Enrollment

30 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months

Exclusion Criteria5

  • Use of probiotic supplements within the last month;
  • Hospitalization within the past month for acute infections or CKD-related complications;
  • History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
  • Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
  • Use of antibiotics or immunosuppressive therapy within the preceding three months.

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Interventions

DIETARY_SUPPLEMENTMultispecies 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

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NCT07443280


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