Trials / Enrolling By Invitation
Enrolling By InvitationNCT07024238
Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients
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
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- Sponsor
- University Hospital, Martin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Metabolic Effects
- Immunosuppressive Agents
- Renal Function
- Adverse Events
- Gut Microbiome
- Flow Cytometry
- Immune System
- Metabolome
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-04-04
- Primary completion
- 2025-09-04
- Completion
- 2025-09-04
- First posted
- 2025-06-17
- Last updated
- 2025-06-17
Locations
1 site across 1 country: Slovakia
Source: ClinicalTrials.gov record NCT07024238. Inclusion in this directory is not an endorsement.