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

What this Trial Is About

Researchers are investigating the effects of multispecies synbiotic supplementation on adults with chronic kidney disease (CKD) who are undergoing maintenance hemodialysis. These patients often experience imbalances in their gut bacteria and increased gut permeability, leading to harmful toxins entering the bloodstream, which may worsen inflammation, cardiovascular risk, and disease progression. This pilot trial aims to explore whether a 12-week synbiotic regimen can improve gut-derived toxins, inflammatory markers, and microbial metabolites in this vulnerable group. Participants will take the Renobiome multispecies synbiotic supplement containing 30 billion colony-forming units (CFUs) per capsule, including specific strains of Lactobacillus and Lactococcus bacteria. The dosing schedule is one capsule twice daily, morning and evening, which can be taken with or without food using room-temperature water. Capsules must be stored in a cool, dry, and light-protected environment. The study includes baseline assessments, a 4-week safety and symptom check, and a 12-week follow-up with repeated blood and urine tests to monitor changes. During the study, participants will undergo various evaluations including blood sampling after fasting to measure serum biochemical markers, inflammatory cytokines (like IL-1, IL-6, TNF-alpha), microbial metabolites such as short-chain fatty acids, and uremic toxins using advanced laboratory techniques. Compliance will be monitored with regular follow-up contacts. The primary outcomes focus on changes in microbial metabolites, serum uremic toxin levels, and inflammatory markers over one year. Safety and adverse events will also be documented throughout the trial.

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