Impact of SCFA Supplementation on Metabolic Profiles in Serum and Urine of Kidney Transplant Recipients.

NCT06951581 | Completed

• 1 other identifier: TNO_UNM_SCFA1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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 transplant recipients. A total of eligible patients will be randomized 1:1 to receive either SCFA or placebo for a period of 12 weeks. Metabolomic profiling of serum and urine will be performed at three time points: at baseline, after 12 weeks of intervention, and after a 12-week washout period without supplementation. The primary objective of the study is to investigate whether SCFA supplementation leads to measurable changes in systemic and renal metabolomic profiles. Secondary outcomes include assessment of tolerability, safety, and potential immunometabolic correlations and also impact on the serum level of immunossupresants (tacrolimus). This study aims to explore the potential of microbiota-targeted therapies in modulating post-transplant metabolic homeostasis.

Conditions

Metabolic Effects; Immunosuppressive Agents; Adverse Events; Imunological Effects; Inflamatory Markers; Metabolomic Effects; Renal Function

Keywords

short chain fatty acids; urine and serum metabolomics; kidney transplant recipients

Outcome Measures

Primary Outcomes (2)

• Change in concentration of serum metabolites after SCFA supplementation

  Quantitative and qualitative changes in the concentration of serum metabolites assessed using targeted metabolomic techniques NMR.

  Baseline to Week 12 and Week 12 to washout period

• Change in concentration of urine metabolites after SCFA supplementation

  Quantitative and qualitative changes in the concentration of urine metabolites assessed using targeted metabolomic techniques NMR.

  Baseline to Week 12 and Week 12 to washout period

Secondary Outcomes (7)

• Incidence of adverse events (AEs) in the contexte of SCFA supplementation

  Baseline to Week 12

• Change in inflammatory biomarkers

  Baseline to Week 12

• Changes in estimated glomerular filtration rate (eGFR).

  Baseline to Week 12 and Week 24

• Tolerability of SCFA supplementation

  Baseline to Week 12

• Change in immunological biomarkers

  Baseline to Week 12

Study Arms (2)

SCFA Group

ACTIVE COMPARATOR

Participants will receive an oral formulation of short-chain fatty acids (SCFA) in dose 200 mg daily for 12 weeks

Dietary Supplement: Short Chain Fatty Acid

Placebo Group

PLACEBO COMPARATOR

Participants will receive a placebo orally (sacharosis in dose 200 mg), matching the SCFA formulation in appearance and administration schedule, for 12 weeks.

Dietary Supplement: Placebo Capsule(s)

Interventions

Short Chain Fatty Acid DIETARY_SUPPLEMENT

Participants in this arm will receive an oral formulation of short-chain fatty acids (SCFAs) daily for 12 weeks. SCFAs are administered as a dietary supplement to investigate their potential impact on the systemic and urinary metabolome in kidney transplant recipients.

SCFA Group

Placebo Capsule(s) DIETARY_SUPPLEMENT

Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Martin

Martin, Slovakia, 03601, Slovakia

Location

MeSH Terms

Interventions

Fatty Acids, Volatile

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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 8, 2025
• First Posted: April 30, 2025
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 30, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

SL (1)