The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 主要终点
- Clinical improvement quality of life within 29 days
研究概览
简要总结
This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome
详细描述
This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome within timeframe of study 28 days and then will be examined the outcome as the improvement quality of life
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind randomized control trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •patient who does not want to sign the inform consent
研究组 & 干预措施
Intervention Group
Get intervention drug Normagut capsule twice a day
干预措施: Saccharomyces Boulardii 250 MG (Drug)
Control Group
Get placebo capsule twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical improvement quality of life within 29 days
时间窗: 29 days
Measuring quality of life using questionnaire IBS-QOL from 0-100, the higher the score, the better the outcome.
次要结局
未报告次要终点
研究者
Marcellus Simadibrata, Prof. PhD., SpPD, KGEH
Professor
Fakultas Kedokteran Universitas Indonesia