NCT01529359已完成不适用
Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Severity of bowel symptoms according to the Francis Score
研究概览
简要总结
The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
详细描述
The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
The secondary purposes are to evaluate the effects of the intervention on:
- quality of life
- severity of fatigue, anxiety and depression
- levels of inflammatory markers in blood and tools
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Irritable bowel syndrome according to the Rome II criteria
- •150< Francis Score < 300
- •HAD score inferior or egal to 25
排除标准
- •History of hypersensitivity to one of the composant of the product
- •Use of probiotics or antibiotics last four weeks
- •use of prohibited drugs
- •bowel preparation for morphological examination last month
- •pregnancy or lactation
- •immundepressed or co-existing other serious illness or evolutive
结局指标
主要结局
Severity of bowel symptoms according to the Francis Score
时间窗: After 6 weeks of complementation
The severity of bowel symptoms is evaluated with a quality of life questionnaire, the Francis Score before and after 6 weeks of complementation in placebo and verum groups.
次要结局
- Impact of the intervention on immunological parameters in blood(after 2 weeks of wash-out)
- Severity of Anxiety/Depression(after 6 weeks of complementation)
- Impact of the complementation on fatigue(After 2 weeks of wash out)
- Quality of life(after 2 weeks of wash-out)
- Severity of bowel symptoms according to the Francis Score(after 2 weeks of wash-out)
- Impact of the intervention on immunological parameters in stools(after 2 weeks of wash out)
- severity of the anxiety/depression(after 2 weeks of wash-out)
研究者
研究点 (2)
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