The Effect of Daily Intake of Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Lewis score area-under-the-curve for Bif195 vs Placebo
研究概览
简要总结
To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population.
详细描述
This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake of 800mg of Ibuprofen.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and Ibuprofen is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits.
After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 800mg of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo product in a ratio of 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy and without any gastrointestinal pain or other significant symptoms
- •Age 18 - 40 years
- •Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
排除标准
- 未提供
研究组 & 干预措施
Bif195 arm
Active trial product with minimum 15 billion CFU daily dose
干预措施: Bif195 (Dietary Supplement)
Placebo arm
Placebo arm. Similar trial product, but without Bif195 bacteria
干预措施: Placebo (Other)
结局指标
主要结局
Lewis score area-under-the-curve for Bif195 vs Placebo
时间窗: 6 weeks
The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
次要结局
未报告次要终点