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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
41
Participants randomized to this group will receive 1000 mg of sodium butyrate daily for 12 weeks. The intervention aims to evaluate the effect of high-dose SCFA supplementation on the gut microbiome and systemic/urinary metabolome in kidney transplant recipients.
Participants in this group will receive placebo capsules (sacharosis) identical in appearance to the active SCFA capsules, administered twice daily for 12 weeks. This arm serves as a control to evaluate the specific effects of SCFA supplementation.
University Hospital Martin
Martin, Slovakia, Slovakia
Change in gut microbiome composition after SCFA supplementation
Evaluation of gut microbiota diversity and composition (alpha and beta diversity indices, relative abundance of microbial taxa) via 16S rRNA gene sequencing from stool samples.
Time frame: Baseline to Week 12
Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation
Analysis of systemic metabolic changes using untargeted metabolomic profiling (NMR) in serum and urine samples and comarisation with results in study TNO\_UNM\_SCFA1.
Time frame: Baseline to Week 12
Safety and tolerability of high-dose SCFA supplementation
Recording of adverse events (AEs), such as gastrointestinal symptoms.
Time frame: Baseline to Week 12
Correlation between gut microbiome composition and serum metabolome.
Exploratory analysis of correlantion between gut microbiome composition and serum metabolites.
Time frame: Baseline to week 12
Intolerance of high dose SCFA.
Recording of treatment discontinuation rates due to intolerance or side effects.
Time frame: Baseline to Week 12.
correlantion between gut microbiome composition and urinary metabolites
Exploratory analysis of correlantion between gut microbiome composition and urinary metabolites.
Time frame: Baseline to week12
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