An interventional study of Short Chain Fatty Acid and Placebo Capsule(s) in Metabolic Effects, Immunosuppressive Agents and Adverse Events, sponsored by University Hospital, Martin. Completed at 1 site in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by University Hospital, Martin · Not applicable, Interventional, and Basic science
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.
University Hospital, Martin is the lead sponsor of 17 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
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 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)
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.
Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.
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
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
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Martin