Evaluation of Effects of Fermented Dairy Products Containing Probiotics Alone or in Association With Fibers on Bowel Functions, Constipation Symptoms and Health Related Quality of Life in Adult Subjects With Moderate Constipation: an Exploratory Randomized Double-blind, Controlled Adaptive Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
研究概览
简要总结
First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
时间窗: Baseline and after 4 weeks.
Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.
时间窗: Baseline and after 4 weeks.
Change in fecal bulk (stool weight) at baseline and after 4 weeks.
时间窗: Baseline and after 4 weeks.
Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.
时间窗: Baseline and after 2 and 4 weeks. Validated questionnaire.
Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.
时间窗: Baseline and after 2 and 4 weeks. Validated questionnaire.
Adverse events in the week before baseline, at baseline, week 3, 4 and 5.
时间窗: Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)
Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.
时间窗: Baseline and during the 4th week.
Study product satisfaction by questionnaire after 2 and 4 weeks.
时间窗: after 2 and 4 weeks.
次要结局
未报告次要终点