RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Tungs' Taichung Metroharbour Hospital • ClinicalTrials.gov ID: NCT07443280

Registry updated: 2026-09-25

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Multispecies Synbiotic Supplementation (Dietary supplement)
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.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months Exclusion Criteria: 1. Use of probiotic supplements within the last month; 2. Hospitalization within the past month for acute infections or CKD-related complications; 3. History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed); 4. Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders; 5. Use of antibiotics or immunosuppressive therapy within the preceding three months.

Conditions

Symbiotic Uremic Toxins Gut -Microbiota

Locations

Tungs' Taichung Metroharbour Hospital — Taichung, Wuqi District, Taiwan

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment