A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Symptom alleviation through the questionnaire IBS-SSS
研究概览
简要总结
The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.
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
- Single (Participant)
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
- 否
入选标准
- •IBS diagnosis
- •Adult (over 18 years)
- •Be able to read/understand/write swedish
排除标准
- •Severe heart failure
- •Severe liver disease
- •Severe neurologic disease
- •Severe psychological disease
- •Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)
结局指标
主要结局
Symptom alleviation through the questionnaire IBS-SSS
时间窗: 4 weeks
IBS-SSS i.e. the IBS Severity Scoring System. To assess the possible change of severity of IBS symptoms. The overall IBS score is calculated ranging from 0 to 500. A higher score implicates more severe symptom.
次要结局
未报告次要终点
研究者
Hans Törnblom
MD, PhD
Sahlgrenska University Hospital, Sweden