NCT03948854已完成不适用
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Improvement in IBS symptoms
研究概览
简要总结
Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.
详细描述
An analysis of different educational programs providing information on the low FODMAP diet will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria
排除标准
- •Subjects who have previously tried the low FODMAP diet (whether successful or not)
- •Current or recent (less than 4 weeks) opioid use
- •Current or recent (less than 10 weeks) rifaximin use
- •Inability to speak or read English
- •Pregnancy and/or breast-feeding
- •Medical or psychological issues that would prevent modifying their diet for 8 weeks.
结局指标
主要结局
Improvement in IBS symptoms
时间窗: Baseline, end of study approximately 8 to 10 weeks
Change in IBS symptoms will be measured from baseline to the end of study using the validated IBS symptoms severity scale (IBS-SS). This is a visual analog scale from 0-100. The primary outcome measure is improvement in symptom scores from end of study to baseline.
次要结局
未报告次要终点
研究者
Brian E. Lacy
Principal Investigator
Mayo Clinic
研究点 (2)
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