NCT06642766尚未招募不适用
Open Label Study of a Novel, Commercially Available Fiber Product for Gas, Bloating, and Bowel Regularity
Bell Cinical Service2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of bowel movement
研究概览
简要总结
This is a new, commercially available, over-the-counter fiber supplement that combines 8 fibers. The varied nature of the fibers in this product is designed to create a more diverse microbiome (bacteria that live within the human GI tract). In general, the more diverse the microbiome the less inflammatory the gut. The purpose of this study is to evaluate the effects of a new fiber product on bloating, gas, and bowel movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Subjects have experienced two or more of the following criteria for at least 3 months with symptom onset at least 6 months prior: straining during at least 25% of defecations, lumpy or hard stools in at least 25% of defecations, sensation of incomplete evacuation for at least 25% of defecations, sensation of anorectal obstruction/blockage for at least 25% of defecations, manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor), loose stools are rarely present without the use of laxatives Or,
- •Subjects have experienced 2 or more of the following criteria of recurrent abdominal pain, for at least 3 months, with symptom onset at least 6 months prior: pain related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool Or,
- •Subjects have experienced 2 or more of the following criteria for at least 3 months, with symptom onset at least 6 months prior: recurrent abdominal pain, on average, at least 1 day per week in the last 3 months associated with two of the following criteria: pain related to defecation, pain associated with a change in frequency of stool and pain associated with a change in form (appearance) of stool.
- •The subject predominantly experiences loose or watery stools (Bristol Stool Form Scale types 6-7), more than 25% of the time, or hard or lumpy stools (types 1-2) less than 25% of the time.
- •The symptoms should be chronic and interfere with daily activities, cause worry or affect the quality of life.
排除标准
- •Loose stools are present for more than 25% of defecations
- •Unable to provide informed consent
- •Hematochezia
- •Prior colon surgery
- •Thyroid disease
- •Pelvic floor disorder
- •Known allergies or intolerance to fiber products
- •infectious diarrhea or food poisoning
- •inflammatory bowel disease, including microscopic colitis
- •fecal incontinence or rectal prolapse
结局指标
主要结局
Number of bowel movement
时间窗: 6 weeks
- The primary endpoint, number of bowel movements, will be assessed by bowel movements in the last 72-hour period at baseline and at 6 weeks, by patient recall/diary.
次要结局
- Bloating(6 weeks)
- Gas(6 weeks)
研究者
研究点 (2)
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