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Completed

NCT Number: NCT06951581

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Martin

Martin, Slovakia, 03601

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short Chain Fatty Acid

Dietary 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.

Primary outcomes

  1. Change in concentration of serum metabolites after SCFA supplementation

    Time frame: 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.

  2. Change in concentration of urine metabolites after SCFA supplementation

    Time frame: 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 outcomes

  1. Incidence of adverse events (AEs) in the contexte of SCFA supplementation

    Time frame: Baseline to Week 12

    Number, type, and severity of AEs assessed through questionnaire, clinical assessment, and lab tests.

  2. Change in inflammatory biomarkers

    Time frame: Baseline to Week 12

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

  3. Changes in estimated glomerular filtration rate (eGFR).

    Time frame: Baseline to Week 12 and Week 24

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

  4. Tolerability of SCFA supplementation

    Time frame: Baseline to Week 12

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

  5. Change in immunological biomarkers

    Time frame: Baseline to Week 12

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

  6. Changes in urine albumine cretinine ratio (UACR).

    Time frame: Baseline to Week 12 and Week 24

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

  7. Changes in the serum level of tacrolimus.

    Time frame: Baseline to Week 12 and Week 24

    Monitoring the serum level of tacrolimus (ng/l) in the context of SCFA supplementation.

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Collaborators

  • Comenius University

Registry information

Official study title

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)

Acronym: METAKID

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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