Status:
COMPLETED
Impact of SCFA Supplementation on Metabolic Profiles in Serum and Urine of Kidney Transplant Recipients.
Lead Sponsor:
University Hospital, Martin
Collaborating Sponsors:
Comenius University
Conditions:
Metabolic Effects
Immunosuppressive Agents
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, double-blind, placebo-controlled clinical trial evaluating the impact of short-chain fatty acid (SCFA) supplementation on the serum and urinary metabolome in stable kidney transp...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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 comply with study procedures and sample collection
Exclusion
- Use of antibiotics or probiotics within 4 weeks prior to enrollment
- Known gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, short bowel syndrome)
- Uncontrolled diabetes mellitus (HbA1c \> 9%)
- Current infection or active malignancy
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within the past 30 days
- Known allergy or intolerance to SCFA formulations or study components (lactose intolerance)
- Severe hepatic impairment (Child-Pugh class C)
- Any condition that, in the opinion of the investigator, may interfere with the participant's ability to complete the study or affect the interpretation of results
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06951581
Start Date
January 15 2024
End Date
July 30 2024
Last Update
June 12 2025
Active Locations (1)
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1
University Hospital Martin
Martin, Slovakia, Slovakia, 03601