Clinical Trial

Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients

Study acronym: RENOBIOME
Enrolling by Invitation
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Record status
This record was last updated June 17, 2025 (before its estimated September 4, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of high-dose short-chain fatty acid (SCFA) supplementation on the gut microbiome and host metabolome in stable kidney transplant recipients. Participants will be randomly assigned to receive either 1000 mg of sodium butyrate per day or placebo for a duration of 12 weeks. Comprehensive profiling of the serum and urinary metabolome, along with analysis of the gut microbiome composition and diversity, will be conducted at three time points: baseline, after the intervention period (week 12). The biochemical parameters and the level of tacrolimus will be also examined.
Trial Details
NCT Number NCT07024238
Lead Sponsor University Hospital, Martin
Collaborators: Comenius University
Conditions Metabolic Effects, Immunosuppressive Agents, Renal Function, Adverse Events, Gut Microbiome, Flow Cytometry, Immune System, Metabolome
Enrollment 41 participants
Start Date 2025-04-04
Primary Completion 2025-09-04 (estimated)
Study Completion 2025-09-04 (estimated)
Updated on ClinicalTrials.gov 2025-06-17