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

Not Applicable

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

• Registration Number: NCT07024238
• Lead Sponsor: University Hospital, Martin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-04
• Study First Submitted: 2025-04-22
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-08
• Last Update Submitted: 2025-06-08
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-09-04
• Study Completion: 2025-09-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Age ≥ 18 years
• Primary kidney transplantation (living or dead donor)

Stable kidney transplant recipients (≥ 6 months post-transplantation)

Stable graft function defined as eGFR ≥ 30 mL/min/1.73 m² with no significant change (>15%) in the last 3 months

No episodes of acute rejection within the last 6 months

On stable immunosuppressive therapy for at least 3 months

Ability to provide written informed consent

Willingness and ability to provide stool, urine, and blood samples at specified time points

Exclusion Criteria

• Use of antibiotics, probiotics, or prebiotics within 4 weeks prior to enrollment

Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, celiac disease)

Severe intestinal motility disorders or chronic diarrhea

Advanced liver disease (Child-Pugh C)

Active infection or systemic inflammatory disease requiring treatment

Uncontrolled diabetes mellitus (HbA1c > 9%)

Known allergy or intolerance to SCFA or ingredients in the supplement

Participation in another interventional clinical trial within the past 30 days

Pregnancy or breastfeeding

Hospitalization within 30 days prior to enrollment

Any condition which, in the opinion of the investigator, may compromise the safety of the participant or the integrity of the study data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in gut microbiome composition after SCFA supplementation	Baseline to Week 12	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.
Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation	Baseline to Week 12	Analysis of systemic metabolic changes using untargeted metabolomic profiling (NMR) in serum and urine samples and comarisation with results in study TNO_UNM_SCFA1.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of high-dose SCFA supplementation	Baseline to Week 12	Recording of adverse events (AEs), such as gastrointestinal symptoms.
Correlation between gut microbiome composition and serum metabolome.	Baseline to week 12	Exploratory analysis of correlantion between gut microbiome composition and serum metabolites.
Intolerance of high dose SCFA.	Baseline to Week 12.	Recording of treatment discontinuation rates due to intolerance or side effects.
correlantion between gut microbiome composition and urinary metabolites	Baseline to week12	Exploratory analysis of correlantion between gut microbiome composition and urinary metabolites.

Trial Locations

Locations (1)

University Hospital Martin; 🇸🇰 Martin, Slovakia