Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins (Phenol and P-Cresol ) in Hemodialysis Patients: A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- pre- and post-treatment p-cresol levels
研究概览
简要总结
Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.
详细描述
Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 20 years
- •Acceptable performance of alimentary system
- •Ability to drink at least 200 ml of water per day
- •No history of being allergic to fungi and yeast
- •Absence of acute medical illness
- •life expectancy more than 3 months
- •Accept and sign the consent
排除标准
- •Patient's unwillingness to participate in the study
- •History of smoking, peritoneal dialysis (PD) or previous kidney transplantation
- •Lactation or pregnancy
- •Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.
研究组 & 干预措施
Lactobacillus rhamnosus
received daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus
干预措施: Lactobacillus rhamnosus (Dietary Supplement)
Placebo
received one placebo capsule per day Infant formula after meal for 28 days
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
pre- and post-treatment p-cresol levels
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
nooshin dalili
assistant Professor of SBMU
Shahid Beheshti University of Medical Sciences