Effects of Probiotic and Synbiotic Administration on the Clinical and Biochemical Characteristics of Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum p-Cresyl Sulfate (PCS)
研究概览
简要总结
This single-center randomized controlled trial evaluated the effects of natural probiotic and synbiotic supplementation on clinical and biochemical characteristics in adults with end-stage renal disease receiving maintenance hemodialysis at the Urology and Nephrology Center, Mansoura University, Egypt. Participants were randomized into three groups (control, probiotic, and synbiotic), with supplementation given for 6 months in the intervention groups. The study assessed changes in uremic toxins (including p-cresyl sulfate) as the primary outcome, and cardiovascular parameters, quality of life, and cognitive function as secondary outcomes. The trial aimed to determine whether modulation of gut microbiota with probiotics or synbiotics can improve outcomes in hemodialysis patients
详细描述
End-stage renal disease patients receiving hemodialysis commonly have intestinal dysbiosis and accumulation of gut-derived uremic toxins. Probiotic and synbiotic supplementation may help modulate gut microbiota and reduce uremic toxin burden, but direct comparative data between probiotic and synbiotic strategies in hemodialysis patients are limited. This study was designed to assess the effects of natural probiotic and synbiotic administration on the clinical and biochemical characteristics and uremic toxin levels of hemodialysis patients at the Urology and Nephrology Center (UNC), Mansoura University, Egypt.
This was a single-center randomized controlled trial with single-blind allocation. Sixty adult patients with end-stage renal disease on regular hemodialysis were included (dropout-inflated sample size; calculated minimum sample size was 48). Participants were randomized into three groups: a control group (20 patients), a probiotic group (20 patients), and a synbiotic group (20 patients). The probiotic and synbiotic groups received supplementation for 6 months; the synbiotic intervention included natural probiotic supplementation combined with prebiotic fibers (oat). Regular hemodialysis was standardized during the trial (3 sessions/week, 4 hours/session).
The primary outcome was the effect of probiotic and synbiotic supplementation on uremic toxin levels, including p-cresyl sulfate. Secondary outcomes included cardiovascular-related parameters and comorbid clinical measures, including body mass index, anemia/ESA resistance, quality of life, and cognitive function. Assessments included laboratory testing (biochemical parameters and uremic toxins), echocardiographic evaluation by blinded cardiologists, and psychological assessment using cognitive testing (MOCA) and quality-of-life evaluation (KDQOL-36).
The completed thesis reports that both probiotic and synbiotic supplementation reduced serum p-cresyl sulfate compared with control, with a more pronounced reduction in the synbiotic group, and that some cardiovascular and quality-of-life parameters improved, while cognitive and other secondary outcomes were less pronounced. Baseline characteristics were comparable across groups, supporting successful randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This was a single-blind randomized trial. Outcome assessors were blinded to group assignment. Echocardiography was performed and interpreted by cardiologists who were unaware of the intervention allocation.
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •End-stage renal disease patients on regular maintenance hemodialysis
- •Not under active preparation for kidney transplantation within the next year (i.e., not planned for transplantation for more than one year)
排除标准
- •Age less than 18 years
- •Under active preparation for kidney transplantation
- •Pregnancy
- •Active malignancy
- •Known structural gastrointestinal tract disease
研究组 & 干预措施
Control (Standard Hemodialysis Care)
Participants received standard maintenance hemodialysis care without probiotic or synbiotic supplementation for the study period.
Probiotic Supplementation
Participants received natural probiotic supplementation in addition to standard maintenance hemodialysis care for 6 months.
干预措施: Natural Probiotic Supplement (Dietary Supplement)
Synbiotic Supplementation
Participants received synbiotic supplementation (natural probiotic plus prebiotic fiber [oat]) in addition to standard maintenance hemodialysis care for 6 months.
干预措施: Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber) (Dietary Supplement)
结局指标
主要结局
Change in Serum p-Cresyl Sulfate (PCS)
时间窗: Baseline and 6 months
Serum p-cresyl sulfate level is measured in blood. Outcome is the change from baseline to the end of the intervention.
次要结局
- Change in Quality of Life (Kidney Disease Quality of Life-36)(Baseline and 6 months)
- Change in Cognitive Function (Montreal Cognitive Assessment)(Baseline and 6 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(Baseline and 6 months)
- Change in Left Ventricular End-Diastolic Volume (LVEDV)(Baseline and 6 months)
- Change in Left Ventricular End-Systolic Volume (LVESV)(Baseline and 6 months)
- Change in Left Ventricular Mass Index (LVMI)(Baseline and 6 months)
- Change in Blood Urea Nitrogen (BUN)(Baseline and 6 months)
- Change in Serum Creatinine(Baseline and 6 months)
- Change in Serum Potassium(Baseline and 6 months)
- Change in Serum Phosphorus(Baseline and 6 months)
- Change in Hemoglobin(Baseline and 6 months)
研究者
Hagar Magdy Abd El-Aziz Farag
Nephrology Resident
Mansoura University