The Effect of Probiotic Intake on Intestinal Permeability of Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Gastroduodenal Permeability
研究概览
简要总结
In this double blind, crossover study participants will take a placebo for 3 weeks each. Gut permeability will be assessed weekly using food-grade sugar molecules. On the second week, participants will take aspirin, which will make their intestine permeable to the sugars. Participants will be asked to provide urine and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the probiotic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.
入排标准
- 年龄范围
- 21 Years 至 50 Years（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
研究组 & 干预措施
Probiotic
2 capsules daily for 3 weeks, containing 3.8 x 10^9 CFU (colony forming units)/capsule of Lactobacillus rhamnosus strain R011and 0.2 x 10^9 CFU/capsule of L. helveticus strain R0052 (group is unknown, double blinded)
干预措施: Probiotic (Dietary Supplement)
Placebo
2 capsules daily for 3 weeks containing the same carrier material and is similar in size, shape and taste to probiotic (group is unknown, double blinded)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Gastroduodenal Permeability
时间窗: Week 2 of each intervention
The primary outcome is the difference between the changes in gastroduodenal permeability induced by aspirin challenge with the probiotic versus the placebo. Gastroduodenal permeability will be assessed while on the placebo and probiotic interventions by measuring urinary sucrose in the 0 to 5-hour urine collection of the sugar probe permeability test. Change will be calculated as the urinary sucrose concentration after aspirin challenge (week 2 of each intervention) minus the concentration from the prior week (i.e., 1 wk on intervention with no aspirin challenge).
次要结局
- Whole Gut Permeability(Weeks 1 and 2 on each intervention)
- Small Intestinal Permeability(Weeks 1 and 2 on intervention)
- Colonic Permeability(Weeks 1 and 2 on intervention)