Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Microbiota / Short chain fatty acids
研究概览
简要总结
IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.
详细描述
IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.
This study will compare the effect of low FODMAPs diet and usual diet instruction on Intestinal flora, intestinal short chain fatty acids and quality of life by two groups.The results will answer the effect and long-term safety of Low FODMAPs diet.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria for Rome Ⅲ
- •IBS patients with diarrhea type
- •By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease
- •Patients be able to communicate well with the researchers and be willing to participate in the study
排除标准
- •Stomach, small intestine, colon surgery history
- •irritable bowel disease (IBD) active period, celiac disease
- •Alcoholics or drug abuse
- •Pregnant or lactating women
- •Recent drug users who use defecation
- •Have a special diet
结局指标
主要结局
Microbiota / Short chain fatty acids
时间窗: Change from baseline Microbiota / Short chain fatty acids at 4 weeks
The fecal samples of IBS patients were analyzed.
次要结局
- Satisfaction questionnaire(1,and 3 month post randomization)
- The Short Form 36 (SF-36) scale(Baseline,1,and 3 month post randomization)
- Irritable bowel syndrome severity scoring system scale(Baseline,1,and 3 month post randomization)
- Irritable bowel syndrome quality of life (IBS-QOL) scale(Baseline,1,and 3 month post randomization)
研究者
Jinsong Wang
Director of Center for Clincal Epidemiology
Yangzhou University