A Randomized Double Blinde Placebo-Controlled Trial of Short-Chain Fatty Acid Supplementation on Graft Function, Inflammatory Profile, and Microbiome Composition After Primary Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in gut microbiome composition after SCFA supplementation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •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
排除标准
- •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
结局指标
主要结局
Change in gut microbiome composition after SCFA supplementation
时间窗: Baseline to Week 12
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.
Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation
时间窗: Baseline to Week 12
Analysis of systemic metabolic changes using untargeted metabolomic profiling (NMR) in serum and urine samples and comarisation with results in study TNO_UNM_SCFA1.
次要结局
- 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)
研究者
Matej Vnucak
deputy head of Transplant-nephrology Department
University Hospital, Martin