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

NCT07024238 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • Metabolic Effects
  • Immunosuppressive Agents
  • Renal Function
  • Adverse Events
  • Gut Microbiome
  • Flow Cytometry
  • Immune System
  • Metabolome

Interventions

DIETARY_SUPPLEMENT

SCFA

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

  • Comenius University

    collaborator OTHER

  • University Hospital, Martin

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-04
Primary Completion
2025-09-04
Completion
2025-09-04

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024238 on ClinicalTrials.gov