Modulation of Gut Microbiota Composition and Gut Permeability Profiles 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 fecal microbiomes
研究概览
简要总结
Chronic kidney disease (CKD) patients undergoing maintenance hemodialysis experience profound alterations in their gut microbiota, leading to dysbiosis and increased gut permeability. This disruption facilitates the translocation of endotoxins and gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate into the systemic circulation, contributing to heightened systemic inflammation, cardiovascular disease risk, and accelerated CKD progression.
Synbiotic supplementation, particularly multispecies formulations, has emerged as a promising therapeutic strategy to restore gut microbial balance, enhance intestinal barrier integrity, and reduce the systemic burden of deleterious microbial metabolites. These probiotics potentially improve clinical outcomes by modulating inflammatory pathways and decreasing circulating levels of uremic toxins.
Despite these insights, few clinical trials have comprehensively assessed the effects of multispecies synbiotic on fecal microbiome composition, gut permeability and uremic toxin profiles in hemodialysis patients. This pilot study aims to fill this gap by evaluating the modulatory effects of a 12-week multispecies synbiotic intervention.
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-derived uremic toxins and fecal microbiota composition over 12 weeks in adults with in a group of hemodialysis patients.
The primary objectives are to:
- Evaluate changes in fecal microbiomes,
- Assess the serum levels of uremic toxins and gut permeability markers
Study Population
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 fecal microbiomes
时间窗: 1 years
This study employed \*\*whole genome sequencing (WGS)\*\* for fecal microbial analysis.Alpha diversity is estimated by species richness using the Chao1 index at the OTU level. A rarefaction curve is generated by randomly selecting a subset of sequencing data from each sample to represent the number of observed species, and a species accumulation curve is plotted to show the occurrence of new OTUs (species) with continuous sampling. For beta diversity, Bray-Curtis dissimilarities at the OTU level are calculated and analyzed using the vegan package. Differential abundance analysis was performed using statistical methods appropriate for compositional microbiome and functional gene data (such as LEfSe, ANCOM-BC, ALDEx2, MaAsLin2, or DESeq2). Multiple hypothesis testing was adjusted using the Benjamini-Hochberg false discovery rate (FDR) correction.
Assess the serum levels of uremic toxins
时间窗: 1 years
Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indole acetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography (HPLC) according to established protocols.
Assess the serum levels of and gut permeability markers
时间窗: 1 years
Quantification of gut permeability markers, such as intestinal fatty acid-binding protein (I-FABP), diamine oxidase (DAO), and zonulin concentrations, using validated ELISA kits.
次要结局
未报告次要终点