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

University Hospital, Martin

Status: Completed

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

Treatments: Dietary Supplement: Short Chain Fatty Acid; Dietary Supplement: Placebo Capsule(s)

Study type: Interventional

Funder types: Other

Identifiers

NCT06951581

TNO_UNM_SCFA1

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups, including a placebo group

SCFA Group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Short Chain Fatty Acid

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Capsule(s)