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

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)

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.

Study Overview

• Status: Completed
• Conditions: Renal Function; Adverse Events; Immunosuppressive Agents; Metabolic Effects; Imunological Effects; Inflamatory Markers; Metabolomic Effects
• Intervention / Treatment: Dietary supplement: Short Chain Fatty Acid; Dietary supplement: Placebo Capsule(s)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Martin, Slovakia, 03601
    • University hospital Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years

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 comply with study procedures and sample collection

Exclusion Criteria:

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

Known gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, short bowel syndrome)

Uncontrolled diabetes mellitus (HbA1c > 9%)

Current infection or active malignancy

Pregnancy or breastfeeding

Participation in another interventional clinical trial within the past 30 days

Known allergy or intolerance to SCFA formulations or study components (lactose intolerance)

Severe hepatic impairment (Child-Pugh class C)

Any condition that, in the opinion of the investigator, may interfere with the participant's ability to complete the study or affect the interpretation of results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SCFA Group; Participants will receive an oral formulation of short-chain fatty acids (SCFA) in dose 200 mg daily for 12 weeks	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.
Placebo Comparator: Placebo Group; Participants will receive a placebo orally (sacharosis in dose 200 mg), matching the SCFA formulation in appearance and administration schedule, for 12 weeks.	Dietary supplement: Placebo Capsule(s); Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in concentration of serum metabolites after SCFA supplementation	Quantitative and qualitative changes in the concentration of serum metabolites assessed using targeted metabolomic techniques NMR.	Baseline to Week 12 and Week 12 to washout period
Change in concentration of urine metabolites after SCFA supplementation	Quantitative and qualitative changes in the concentration of urine metabolites assessed using targeted metabolomic techniques NMR.	Baseline to Week 12 and Week 12 to washout period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) in the contexte of SCFA supplementation	Number, type, and severity of AEs assessed through questionnaire, clinical assessment, and lab tests.	Baseline to Week 12
Change in inflammatory biomarkers	Exploratory analysis of inflammatory markers (CRP, leukocytosis) to assess potential immunomodulatory effects of SCFA.	Baseline to Week 12
Tolerability of SCFA supplementation	The patient tolerability of SCFA suplementation or placebo assessed through questionnaire.	Baseline to Week 12
Change in immunological biomarkers	Exploratory analysis of immunological markers (T cell subsets) to assess potential immunomodulatory effects of SCFA.	Baseline to Week 12
Changes in urine albumine cretinine ratio (UACR).	Monitoring renal function using UACR in the context of using SCFA or placebo.	Baseline to Week 12 and Week 24
Changes in estimated glomerular filtration rate (eGFR).	Monitoring renal function using eGFR (ml/min/1.73m2) calculated by CKD-EPI.	Baseline to Week 12 and Week 24
Changes in the serum level of tacrolimus.	Monitoring the serum level of tacrolimus (ng/l) in the context of SCFA supplementation.	Baseline to Week 12 and Week 24

Collaborators and Investigators

• Sponsor: University Hospital, Martin
• Collaborators: Comenius University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 8, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: kidney transplant recipients; short chain fatty acids; urine and serum metabolomics
• Other Study ID Numbers: TNO_UNM_SCFA1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No