Metabolic Effects, Immunosuppressive Agents, Adverse Events, Imunological Effects, Inflamatory Markers, Metabolomic Effects, Renal Function
Conditions
Keywords
short chain fatty acids, urine and serum metabolomics, kidney transplant recipients
Brief 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.
Interventions
DIETARY_SUPPLEMENTPlacebo Capsule(s)
Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.
DIETARY_SUPPLEMENTShort 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.
Sponsors
Comenius University
University Hospital, Martin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in concentration of serum metabolites after SCFA supplementation | Baseline to Week 12 and Week 12 to washout period | Quantitative and qualitative changes in the concentration of serum metabolites assessed using targeted metabolomic techniques NMR. |
| Change in concentration of urine metabolites after SCFA supplementation | Baseline to Week 12 and Week 12 to washout period | Quantitative and qualitative changes in the concentration of urine metabolites assessed using targeted metabolomic techniques NMR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory biomarkers | Baseline to Week 12 | Exploratory analysis of inflammatory markers (CRP, leukocytosis) to assess potential immunomodulatory effects of SCFA. |
| Changes in estimated glomerular filtration rate (eGFR). | Baseline to Week 12 and Week 24 | Monitoring renal function using eGFR (ml/min/1.73m2) calculated by CKD-EPI. |
| Change in immunological biomarkers | Baseline to Week 12 | Exploratory analysis of immunological markers (T cell subsets) to assess potential immunomodulatory effects of SCFA. |
| Changes in urine albumine cretinine ratio (UACR). | Baseline to Week 12 and Week 24 | Monitoring renal function using UACR in the context of using SCFA or placebo. |
| Changes in the serum level of tacrolimus. | Baseline to Week 12 and Week 24 | Monitoring the serum level of tacrolimus (ng/l) in the context of SCFA supplementation. |
| Tolerability of SCFA supplementation | Baseline to Week 12 | The patient tolerability of SCFA suplementation or placebo assessed through questionnaire. |
| Incidence of adverse events (AEs) in the contexte of SCFA supplementation | Baseline to Week 12 | Number, type, and severity of AEs assessed through questionnaire, clinical assessment, and lab tests. |
Countries
Slovakia
Outcome results
None listed