NCT01373034Unknown不适用
The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- sum of irritable bowel syndrome symptom score
研究概览
简要总结
The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing to consent/undergo necessary procedures
- •between the age of 19 and 75 years
- •diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)
排除标准
- •uncontrolled hypertension (Blood pressure > 170/100 mmHg)
- •uncontrolled diabetes mellitus (FBS > 180 mg/dL)
- •malignancy, cerebrovascular disease, cardiovascular disease
- •history of abdominal surgery except appendectomy and hernia repair
- •inflammatory bowel disease
- •clinically or laboratory-confirmed gastroenteritis
- •the use of motility drug or dietary fiber supplement in 2 weeks
- •allergy to soy fiber
- •serum Cr > 2 x Upper normal limit
- •AST or ALT > 2 x Upper normal limit
- •Pregnancy, Lactating woman
结局指标
主要结局
sum of irritable bowel syndrome symptom score
时间窗: after 4 weeks
abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
次要结局
- irritable bowel syndrome symptom score(after 2 weeks and 4 weeks)
- Stool frequency and form(after 2 weeks and 4 weeks)
- Symptom control of irritable bowel syndrome(after 2 weeks and 4 weeks)
- Improvement of overall symptom in patient with irritable bowel syndrome(after 2 weeks and 4 weeks)
- Severity of overall symptom in patient with irritable bowel syndrome(after 2 weeks and 4 weeks)
- Severity of diarrhea(after 2 weeks and 4 weeks)
- Assessment for quality of life related with irritable bowel syndrome(after 2 weeks and 4 weeks)
- Assessment for patient satisfaction after administration completion(after 2 weeks and 4 weeks)
研究者
研究点 (2)
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