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Enrolling by Invitation

NCT Number: NCT07024238

Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients

This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of high-dose short-chain fatty acid (SCFA) supplementation on the gut microbiome and host metabolome in stable kidney transplant recipients. Participants will be randomly assigned to receive either 1000 mg of sodium butyrate per day or placebo for a duration of 12 weeks. Comprehensive profiling of the serum and urinary metabolome, along with analysis of the gut microbiome composition and diversity, will be conducted at three time points: baseline, after the intervention period (week 12). The biochemical parameters and the level of tacrolimus will be also examined.

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Key information

Conditions

Metabolic Effects Adverse Events Flow Cytometry Gut Microbiome Immune System Immunosuppressive Agents Metabolome 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
  • Primary kidney transplantation (living or dead donor)

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 provide stool, urine, and blood samples at specified time points

Exclusion criteria

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

Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, celiac disease)

Severe intestinal motility disorders or chronic diarrhea

Advanced liver disease (Child-Pugh C)

Active infection or systemic inflammatory disease requiring treatment

Uncontrolled diabetes mellitus (HbA1c > 9%)

Known allergy or intolerance to SCFA or ingredients in the supplement

Participation in another interventional clinical trial within the past 30 days

Pregnancy or breastfeeding

Hospitalization within 30 days prior to enrollment

Any condition which, in the opinion of the investigator, may compromise the safety of the participant or the integrity of the study data

Treatment and study plan

SCFA

Dietary Supplement

Participants randomized to this group will receive 1000 mg of sodium butyrate daily for 12 weeks. The intervention aims to evaluate the effect of high-dose SCFA supplementation on the gut microbiome and systemic/urinary metabolome in kidney transplant recipients.

Placebo

Dietary Supplement

Participants in this group will receive placebo capsules (sacharosis) identical in appearance to the active SCFA capsules, administered twice daily for 12 weeks. This arm serves as a control to evaluate the specific effects of SCFA supplementation.

Primary outcomes

  1. Change in gut microbiome composition after SCFA supplementation

    Time frame: Baseline to Week 12

    Evaluation of gut microbiota diversity and composition (alpha and beta diversity indices, relative abundance of microbial taxa) via 16S rRNA gene sequencing from stool samples.

  2. Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation

    Time frame: Baseline to Week 12

    Analysis of systemic metabolic changes using untargeted metabolomic profiling (NMR) in serum and urine samples and comarisation with results in study TNO_UNM_SCFA1.

Secondary outcomes

  1. Safety and tolerability of high-dose SCFA supplementation

    Time frame: Baseline to Week 12

    Recording of adverse events (AEs), such as gastrointestinal symptoms.

  2. Correlation between gut microbiome composition and serum metabolome.

    Time frame: Baseline to week 12

    Exploratory analysis of correlantion between gut microbiome composition and serum metabolites.

  3. Intolerance of high dose SCFA.

    Time frame: Baseline to Week 12.

    Recording of treatment discontinuation rates due to intolerance or side effects.

  4. correlantion between gut microbiome composition and urinary metabolites

    Time frame: Baseline to week12

    Exploratory analysis of correlantion between gut microbiome composition and urinary metabolites.

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Collaborators

  • Comenius University

Registry information

Official study title

A Randomized Double Blinde Placebo-Controlled Trial of Short-Chain Fatty Acid Supplementation on Graft Function, Inflammatory Profile, and Microbiome Composition After Primary Kidney Transplantation

Acronym: RENOBIOME

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 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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