Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients (NCT07024238) | Clinical Trial Compass
By InvitationNot Applicable
Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients
Slovakia41 participantsStarted 2025-04-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in gut microbiome composition after SCFA supplementation
Timeframe: Baseline to Week 12
2
Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation