Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic Supplementation in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate changes in levels of microbial metabolites
研究概览
简要总结
Patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis frequently exhibit significant gut microbiota dysbiosis and increased intestinal permeability. These alterations enable the translocation of endotoxins and gut-derived uremic toxins-such as indoxyl sulfate and p-cresyl sulfate-into the systemic circulation, exacerbating systemic inflammation, elevating cardiovascular risk, and accelerating disease progression.
Multispecies synbiotic supplementation has emerged as a promising intervention to restore gut microbial equilibrium, strengthen intestinal barrier function, and reduce the systemic load of harmful microbial metabolites. Through modulation of inflammatory pathways and reduction of circulating uremic toxins, synbiotic hold potential to improve clinical outcomes in this vulnerable population.
Although preclinical and some clinical evidence suggests benefits of probiotic therapy, comprehensive clinical trials specifically examining multispecies synbiotic effects on gut inflammatory markers, gut derived metabolite profiles, and uremic toxin levels in hemodialysis patients remain limited. This pilot study aims to address this gap by investigating the biological and clinical effects of a 12-week multispecies regimen in adult maintenance hemodialysis patients.
详细描述
Study Design and Objectives This investigation is a single-arm, open-label pilot trial designed to assess the impact of a multispecies synbiotic supplementation on gut microbial metabolites, markers of inflammation, and gut-derived uremic toxins (GDUTs) over 12 weeks in adults with in a group of hemodialysis patients.
Sample Size Justification This pilot study targets 30 participants, which provides adequate power (80%, alpha 0.05) to detect a medium effect size (Cohen's d = 0.6) on the primary outcome, serum indoxyl sulfate levels. Calculations based on expected changes from 8.0 mg/L to 6.5 mg/L with SD of 2.5 mg/L indicate a required sample size of ~24; the sample size accounts for potential dropouts to ensure study robustness.
Study Procedures
- Baseline assessments:
- Collection of serum biochemical markers,
- Measurement of serum and urine uremic toxins,
- Quantification of microbial metabolites.
- Intervention:
Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
排除标准
- •Use of probiotic supplements within the last month;
- •Hospitalization within the past month for acute infections or CKD-related complications;
- •History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
- •Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
- •Use of antibiotics or immunosuppressive therapy within the preceding three months.
研究组 & 干预措施
Multispecies synbiotic
Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358.
- Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water.
- Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.
干预措施: Multispecies Synbiotic Supplementation (Dietary Supplement)
结局指标
主要结局
Evaluate changes in levels of microbial metabolites
时间窗: 1 years
Measurement of microbial metabolites (SCFA, e.g., butyric acid), indolelactic acid (ILA), and indolepropionic acid (IPA) concentrations.
Measurement of serum uremic toxins
时间窗: 1 years
• Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indoleacetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography-mass spectrometry (HPLC-MS)
Assess modulation of inflammatory markers
时间窗: 1 years
• Quantification of inflammatory cytokines (IL-1, IL-6, TNF-α) Concentrations using validated ELISA kits.
次要结局
未报告次要终点