NCT02548247已完成不适用
Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation
Beneo GmbH2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Stool frequency determined by daily questionnaire
研究概览
简要总结
Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- •Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months.
- •Age ≥ 20 and ≤ 75
排除标准
- •Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries.
- •Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial.
- •Subjects with stool frequency of <1 stool every 7 days or more than 3 stools per week.
结局指标
主要结局
Stool frequency determined by daily questionnaire
时间窗: 4 weeks
Stool frequency determined by daily questionnaire.
次要结局
- Faecal microbiota composition determined by illumina sequencing(4 weeks)
- Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)(4 weeks)
- Stool metabolite profiling determined by GC/LC-MS(4 weeks)
- Questionnaire on Gastrointestinal characteristics(4 weeks)
- Stool consistency rated according to the Bristol Stool Form Scale(4 weeks)
研究者
研究点 (2)
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