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
- 1
- 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
- •Experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (Bristol stool scale of 5 or greater).
- •Subjects aged 18 and older meeting the Rome III criteria for Functional Fecal incontinence diagnostic criteria:
- •Recurrent uncontrolled passage of fecal material in an individual and one or more of the following:
- •Abnormal functioning of normally innervated and structurally intact muscles
- •Minor abnormalities of sphincter structure and/or innervation
- •Normal or disordered bowel habits, (i.e., diarrhea) Criteria fulfilled for the last 3 months
排除标准
- •Abnormal innervation caused by lesion(s) within the brain (e.g., dementia), spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple sclerosis), or as part of a generalized peripheral or autonomic neuropathy
- •Anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma)
- •Structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence
- •Have cognitive dysfunction or unable to understand or provide written informed consent
- •FI with solid stool only
- •Comorbid medical problems that may affect gastrointestinal transit or motility: Inflammatory bowel disease, Extraintestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.),Severe renal or hepatic disease
- •Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery.
- •. Previous treatment with low FODMAP diet.
- •Concurrent medications not permitted including probiotics, antibiotics, and narcotics.
- •Active participation in another form of dietary therapy.
研究组 & 干预措施
low fodmap diet
Subjects receive formalized teaching in low fodmap diet by a dietician
干预措施: low fodmap diet (Other)
psyllium
subjects receive 7.1 g of psyllium daily
干预措施: Psyllium (Dietary Supplement)
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