Department of Nutrition, China Medical University
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The change of depression score
研究概览
简要总结
As the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients. Besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population. Both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients. Therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients. This is a randomized controlled trial. All patients will be assigned at random to intervention group or control group. This study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period. The investigators provide probiotics (C. butyricum MIYAIRI 588) to intervention group and provide nothing to the control group.
All patients need to maintain the lifestyle during study period. Genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adults aged 20 years or older undergoing hemodialysis (at least 3 months), 3 times per week, and URR ≥65%
排除标准
- •allergic to the components of the intervention drug, low tolerance of milk or dairy products
- •Has the diagnosis of dementia, delirium, bipolar disorder, schizophrenia, or liver failure
- •Beck Depression Inventory Chinese version 2.0 score higher than 14, or has significant suicide risk during study
- •Following significantly clinical syndrome: obsessive compulsive disorder, schizoid personality disorder, schizotypal personality, paranoid、antisocial Personality Disorder, histrionic personality disorder
- •With addiction to alcohol or drugs, terminal cancer, severe infection, heart failure, central venous catheter in the past 6 months
- •Taking antibiotics, anti-oxidant vitamin supplement, probiotics, prebiotics, antidepressants, anti-anxiety medicine, yogurt and the products in the past 3 months
- •Pregnant or lactating
研究组 & 干预措施
Intervention
干预措施: MIYAIRI 588 (Drug)
结局指标
主要结局
The change of depression score
时间窗: Change from Baseline depression score at 3 months
Beck Depression Inventory score (Chinese version 2.0). The score range is from 0 to 63, and the higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
Pei-Yu Wu
Project Assistant Professor
China Medical University Hospital