NCT01738607已完成不适用
The Impact of Fiber Fermentation on Fecal Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- self-report of an incontinent episode on a daily stool diary
研究概览
简要总结
The primary aim of this study was to compare the effects of supplementation with one of three dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on fecal incontinence (FI), symptom intolerance, and quality of life in community-living individuals who have incontinence of loose or liquid feces. A secondary aim was to explore the possible mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool consistency, water-holding capacity or gel formation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •living in the community (not a nursing home or assisted living facility)
- •self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period
- •toilets independently
- •ability to read and write in English.
- •Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI criteria were also eligible.
排除标准
- •difficulty swallowing,
- •a gastrointestinal (GI) tract altered by surgery,
- •a malabsorption disorder,
- •inflammatory bowel disease,
- •gastrointestinal cancer or active cancer treatment,
- •allergy to the fibers,
- •regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications.
- •a score ≤24 on the Mini Mental State Examination
- •having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period
结局指标
主要结局
self-report of an incontinent episode on a daily stool diary
the date and time of an incontinence episode was reported and the ratio of the number of incontinence episodes to total stools daily was calculated
次要结局
- self-report of gastro-intestinal symptoms on a daily symptom record
- Total dietary fiber content of feces
- wet and dry weights of collected stools and percentage of water content
- Gel formation of non-frozen stools
- amount of fecal incontinence
- self-report of quality of life
- Water-holding capacity of non-frozen of stools
- Self-report of amount of supplement consumed
研究者
研究点 (2)
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