A Randomized, Placebo-controlled Trial Investigating the Effect of Short-chain Fatty Acid (SCFA) Supplementation on Serum and Urinary Metabolome in Kidney Transplant Recipients (METAKID Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in concentration of serum metabolites after SCFA supplementation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SCFA Group
Participants will receive an oral formulation of short-chain fatty acids (SCFA) in dose 200 mg daily for 12 weeks
干预措施: Short Chain Fatty Acid (Dietary Supplement)
Placebo Group
Participants will receive a placebo orally (sacharosis in dose 200 mg), matching the SCFA formulation in appearance and administration schedule, for 12 weeks.
干预措施: Placebo Capsule(s) (Dietary Supplement)
结局指标
主要结局
Change in concentration of serum metabolites after SCFA supplementation
时间窗: Baseline to Week 12 and Week 12 to washout period
Quantitative and qualitative changes in the concentration of serum metabolites assessed using targeted metabolomic techniques NMR.
Change in concentration of urine metabolites after SCFA supplementation
时间窗: Baseline to Week 12 and Week 12 to washout period
Quantitative and qualitative changes in the concentration of urine metabolites assessed using targeted metabolomic techniques NMR.
次要结局
- Incidence of adverse events (AEs) in the contexte of SCFA supplementation(Baseline to Week 12)
- Change in inflammatory biomarkers(Baseline to Week 12)
- Tolerability of SCFA supplementation(Baseline to Week 12)
- Change in immunological biomarkers(Baseline to Week 12)
- Changes in urine albumine cretinine ratio (UACR).(Baseline to Week 12 and Week 24)
- Changes in estimated glomerular filtration rate (eGFR).(Baseline to Week 12 and Week 24)
- Changes in the serum level of tacrolimus.(Baseline to Week 12 and Week 24)
研究者
Matej Vnucak
deputy head of Transplant-nephrology Department
University Hospital, Martin