NCT06951581

Impact of SCFA Supplementation on Metabolic Profiles in Serum and Urine of Kidney Transplant Recipients.

A Randomized, Placebo-controlled Trial Investigating the Effect of Short-chain Fatty Acid (SCFA) Supplementation on Serum and Urinary Metabolome in Kidney Transplant Recipients (METAKID Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University Hospital, Martin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled clinical trial evaluating the impact of short-chain fatty acid (SCFA) supplementation on the serum and urinary metabolome in stable kidney transplant recipients. A total of eligible patients will be randomized 1:1 to receive either SCFA or placebo for a period of 12 weeks. Metabolomic profiling of serum and urine will be performed at three time points: at baseline, after 12 weeks of intervention, and after a 12-week washout period without supplementation. The primary objective of the study is to investigate whether SCFA supplementation leads to measurable changes in systemic and renal metabolomic profiles. Secondary outcomes include assessment of tolerability, safety, and potential immunometabolic correlations and also impact on the serum level of immunossupresants (tacrolimus). This study aims to explore the potential of microbiota-targeted therapies in modulating post-transplant metabolic homeostasis.

Conditions

• Metabolic Effects
• Immunosuppressive Agents
• Adverse Events
• Imunological Effects
• Inflamatory Markers
• Metabolomic Effects
• Renal Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Short Chain Fatty Acid	Participants in this arm will receive an oral formulation of short-chain fatty acids (SCFAs) daily for 12 weeks. SCFAs are administered as a dietary supplement to investigate their potential impact on the systemic and urinary metabolome in kidney transplant recipients.
DIETARY_SUPPLEMENT	Placebo Capsule(s)	Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-07-15
• Completion: 2024-07-30
• First posted: 2025-04-30
• Last updated: 2025-06-12

Locations

1 site across 1 country: Slovakia