Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCFA, Placebo.
- Who it may be relevant to
- Registry conditions: Metabolic Effects, Immunosuppressive Agents, Renal Function, Adverse Events. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Dietary supplement SCFA
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. - Dietary supplement Placebo
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 outcome measures
- Change in gut microbiome composition after SCFA supplementation [Time frame: Baseline to Week 12]
- Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation [Time frame: Baseline to Week 12]
Secondary outcome measures (4)
- Safety and tolerability of high-dose SCFA supplementation [Time frame: Baseline to Week 12]
- Correlation between gut microbiome composition and serum metabolome. [Time frame: Baseline to week 12]
- Intolerance of high dose SCFA. [Time frame: Baseline to Week 12.]
- correlantion between gut microbiome composition and urinary metabolites [Time frame: Baseline to week12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Slovakia · 1 center
- University Hospital Martin — Martin
Identifiers
NCT: NCT07024238 · TNO_UNM_SCFA2