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

University Hospital, Martin41 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Metabolic Effects Immunosuppressive Agents Adverse Events

Interventions

Short Chain Fatty AcidDIETARY_SUPPLEMENT

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 Capsule(s)DIETARY_SUPPLEMENT

Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline to Week 12 and Week 12 to washout period

Secondary Outcomes

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.

Time frame: Baseline to Week 12

Change in inflammatory biomarkers

Exploratory analysis of inflammatory markers (CRP, leukocytosis) to assess potential immunomodulatory effects of SCFA.

Time frame: Baseline to Week 12

Changes in estimated glomerular filtration rate (eGFR).

Monitoring renal function using eGFR (ml/min/1.73m2) calculated by CKD-EPI.

Time frame: Baseline to Week 12 and Week 24

Tolerability of SCFA supplementation

The patient tolerability of SCFA suplementation or placebo assessed through questionnaire.

Time frame: Baseline to Week 12

Change in immunological biomarkers

Exploratory analysis of immunological markers (T cell subsets) to assess potential immunomodulatory effects of SCFA.

Time frame: Baseline to Week 12

Changes in urine albumine cretinine ratio (UACR).

Monitoring renal function using UACR in the context of using SCFA or placebo.

Time frame: 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.

Time frame: Baseline to Week 12 and Week 24

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes