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

NCT07024238 | Enrolling By Invitation

• 1 other identifier: TNO_UNM_SCFA2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

short chain fatty acids; gut microbiome; kidney transplant recipients

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to Week 12

Secondary Outcomes (4)

• Safety and tolerability of high-dose SCFA supplementation

  Baseline to Week 12

• Correlation between gut microbiome composition and serum metabolome.

  Baseline to week 12

• Intolerance of high dose SCFA.

  Baseline to Week 12.

• correlantion between gut microbiome composition and urinary metabolites

  Baseline to week12

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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.

SCFA group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Martin: lead
• Comenius University: collaborator

Study Sites (1)

University Hospital Martin

Martin, Slovakia, 03601, Slovakia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy head of Transplant-nephrology Department

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 17, 2025
• Study Start: April 4, 2025
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)