Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Intestinal permeability
研究概览
简要总结
The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.
详细描述
Increased intestinal permeability are related to the major complications of liver cirrhosis. The administration of probiotics has been suggested to improve the barrier function of the mucosa and consequently avoid the complications of the disease. The objective of this study was to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.
Eighteen patients were treated with Saccharomyces boulardii. Intestinal permeability (lactulose/mannitol ratio) and laboratory parameters were evaluated immediately before the beginning of treatment, after a thirty-day period of treatment with probiotic and at the end of the second study month (after a thirty-day period without treatment with probiotic). Twenty healthy volunteers were also submitted for the intestinal permeability test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients in the waiting list for liver transplant with viral, alcoholic or cryptogenic cirrhosis
排除标准
- •patients younger than 18 years or older than 65 years.
- •patients with renal failure, congestive heart failure, nephrotic syndrome, diabetes and thyroid diseases that interfered with absorption, flux of water and solutes and intestinal motility, in order to avoid interference with the intestinal permeability tests
研究组 & 干预措施
S. boulardii 200mg (Floratil®)
The patients received S. boulardii every 8h during 30 days as an oral capsule formulation which contained 200 mg lyophilized S. boulardii-17 (Floratil®).
The patients enrolled in the study were evaluated immediately before the beginning of treatment, after a thirty-day period of treatment with probiotic and at the end of the second study month (after a thirty-day period without treatment with probiotic).
干预措施: Saccharomyces boulardii (Drug)
结局指标
主要结局
Intestinal permeability
时间窗: Change from intestinal permeability at two months
Intestinal permeability test was conducted at the lactulose and mannitol excretion
次要结局
- Effect of Saccharomyces boulardii on laboratory parameters(Change from laboratory parameters in two months)
- Number of participants with adverse effect(Adverse effect in two months)
研究者
Juliana Costa Liboredo
Fellow PhD degree
Federal University of Minas Gerais