NCT01171014已完成2 期
A Three-Arm, Placebo Controlled, Double-Blind, Single Center Study to Evaluate the Impact of Probiotic Strain Bifidobacterium Lactis HN019 on Intestinal Well-Being, Colonic Transit Time and Digestive Discomfort
Fonterra Research Centre0 个研究点目标入组 100 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Colonic transit time
研究概览
简要总结
The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy males and females aged 25 to 65 years
- •stool type 2-4 on the Bristol Stool Chart
- •1 to 3 bowel movements per week
排除标准
- •use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
- •major chronic and uncontrolled systemic medical conditions
- •severe gastrointestinal conditions known to prolong CTT
- •lactose intolerance
- •chronic diarrhea
- •gastric bypass surgery or lap band insertion for weight loss
- •regular laxative use
- •pregnant or breast-feeding women
结局指标
主要结局
Colonic transit time
时间窗: 14 days
次要结局
- Gastrointestinal symptoms(14 days)
研究者
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