Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in number of FI episodes from baseline to week 4
研究概览
简要总结
Background:
Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed.
Aims:
- Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI.
- Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints.
Methods:
This is a prospective, randomized control trial of adults meeting the Rome III criteria for FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total of 20 patients will be recruited for each arm.
The primary endpoint will be treatment response based on number of incontinence episodes. A treatment response is defined as a reduction in the number of FI episodes/week.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in number of FI episodes from baseline to week 4
时间窗: 4 weeks from baseline
Will compare baseline number of FI episodes to number of FI episodes at week 4
次要结局
- Change in Fecal incontinence quality of life measure (FIqol)(4 weeks from baseline)
- number of people responding with decreased score in stool consistency(4 week span from baseline)
- Change in Fecal incontinence severity index (FISI)(4 weeks from baseline)
- Change in Short Form Health survey-36(4 weeks from baseline)
- Number of participants with reduction in fecal incontinence episodes of ≥50% during weeks 3 & 4 of each diet compared with baseline(4 weeks from baseline)
- number of people responding with reduction in stool frequency(4 weeks from baseline)
- Change in stool wet weight(4 weeks from baseline)
研究者
Stacy Menees
Assistant Professor
University of Michigan