NCT00355810已完成不适用
Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Satisfactory relief of abdominal symptoms
研究概览
简要总结
This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable bowel syndrome according to the Rome II criteria
- •regular symptoms
排除标准
- •Use of probiotics last three weeks
- •pregnancy
- •lactation
- •co-existing other gastrointestinal disorders
- •use of laxatives and antibiotics within last 5 weeks.
结局指标
主要结局
Satisfactory relief of abdominal symptoms
时间窗: 11 weeks
relief of symptoms recorded on diary cards
次要结局
- Graded measurement of abdominal symptoms(11 weeks)
- Fecal bacterial count(11 weeks)
- Abdominal gas(11 weeks)
- Immunological parameters(11 weeks)
研究者
研究点 (2)
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