Metabolic EffectsRENOBIOMENCT07024238
Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients
A study testing SCFA in people with Metabolic Effects and Immunosuppressive Agents, run by University Hospital, Martin at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Effects, Immunosuppressive Agents, Renal Function
- What is being tested?
- SCFA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSlovakia
- Study dates
- 4 Apr 2025to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- SCFA, Placebo
- Keywords
- short chain fatty acids, gut microbiome, kidney transplant recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCFADietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| SCFA group | Experimental | Participants randomized at study with ID: TNO_UNM_SCFA1 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. The effect of different dosage of SCFA between study TNO_UNM_SCFA1 and TNO_UNM_SCFA2 will be examined also. Receives: Dietary Supplement: SCFA |
| Placebo group | Placebo comparator | Participants in this group will receive placebo capsules 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiome composition after SCFA supplementation
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.
Measured: Baseline to Week 12
Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation
Analysis of systemic metabolic changes using untargeted metabolomic profiling (NMR) in serum and urine samples and comarisation with results in study TNO_UNM_SCFA1.
Measured: Baseline to Week 12
Secondary outcomes (4)
Safety and tolerability of high-dose SCFA supplementation
Recording of adverse events (AEs), such as gastrointestinal symptoms.
Measured: Baseline to Week 12
Correlation between gut microbiome composition and serum metabolome.
Exploratory analysis of correlantion between gut microbiome composition and serum metabolites.
Measured: Baseline to week 12
Intolerance of high dose SCFA.
Recording of treatment discontinuation rates due to intolerance or side effects.
Measured: Baseline to Week 12.
correlantion between gut microbiome composition and urinary metabolites
Exploratory analysis of correlantion between gut microbiome composition and urinary metabolites.
Measured: Baseline to week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start4 Apr 2025
- Primary completion4 Sep 2025 (estimated)
- Study completion4 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024238
- Sponsor's protocol ID
- TNO_UNM_SCFA2
- Acronym
- RENOBIOME
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07024238
- Acronym / sponsor ID
- RENOBIOME / TNO_UNM_SCFA2
- Conditions
- Metabolic Effects, Immunosuppressive Agents, Renal Function, Adverse Events, Gut Microbiome, Flow Cytometry
- Keywords
- short chain fatty acids, gut microbiome, kidney transplant recipients
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Collaborators
- Comenius University
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 4 Sep 2025 (estimated)
- Study completion
- 4 Sep 2025 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCFA group | Experimental | Dietary Supplement: SCFAParticipants randomized at study with ID: TNO_UNM_SCFA1 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. The effect of different dosage of SCFA between study TNO_UNM_SCFA1 and TNO_UNM_SCFA2 will be examined also. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will receive placebo capsules 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCFAParticipants 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 | SCFA group |
| PlaceboParticipants 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. | Dietary supplement | Placebo group |
Primary outcome
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCFA in people with Metabolic Effects and Immunosuppressive Agents, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome composition after SCFA supplementation (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.