Effect of Bifidobacterium on Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adequate relief and SIBSQ
研究概览
简要总结
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.
详细描述
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IBS with Rome II definition
排除标准
- •Diagnosis of serious diseases (both physically and mentally)
研究组 & 干预措施
A
Bifidobacterium breve
干预措施: Bifidobacterium breve (Drug)
B
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adequate relief and SIBSQ
时间窗: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
次要结局
- Psychometric test, bowel gas, blood, and feces.(2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment)