Study of Multispecies Synbiotic Supplement to Improve Gut Health and Reduce Toxins in Adults on Hemodialysis

What this Trial Is About

Chronic kidney disease CKD patients on maintenance hemodialysis often experience significant changes in their gut bacteria, leading to harmful imbalances and increased gut leakiness. This allows toxins from the gut to enter the bloodstream, contributing to inflammation, heart disease risk, and faster CKD progression. Researchers are studying how a multispecies synbiotic supplement might improve these gut issues and reduce harmful toxins in hemodialysis patients. Participants will take a multispecies synbiotic supplement called Renobiome, containing 30 billion colony-forming units per capsule from several Lactobacillus strains and Lactococcus lactis. The supplement is taken twice daily for 12 weeks, with or without food. The study includes baseline tests of blood, urine, and stool samples, followed by monitoring of symptoms and side effects at 4 weeks and repeat testing at 12 weeks. During the trial, participants will have fasting blood samples collected and analyzed for uremic toxins and gut permeability markers. Stool samples will be examined to assess changes in gut bacteria. Adherence to the supplement will be tracked, and any adverse events will be recorded. The main outcomes measured are changes in fecal microbiome composition and serum levels of uremic toxins and gut permeability markers over one year.

Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients