Changes in the Gut Microbiota Composition of Healthy Young Volunteers After Administration of Lacticaseibacillus Rhamnosus LRa05: A Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- intestinal flora test
研究概览
简要总结
Purpose: to verify the physiological properties of Lactobacillus rhamnosus LRa05.
Bacterial count:100 billion Test Objective: to test and collect the changes of intestinal flora before and after the daily use of LRa05 product.
详细描述
In order to validate the physiological properties of the 100 billion probiotic Lactobacillus rhamnosus LRa05 product and to gather sufficient evidence to test the changes in the intestinal flora before and after the daily use of the probiotic product, the test was conducted on 110 college students aged 18-25 years.
The primary outcome was to investigate the increase in the diversity of the gut flora and the increase in the peak levels of beneficial bacteria in the gut, and the secondary outcome was to investigate whether there was a significant improvement in the PSQI Pittsburgh Sleep Quality Index and the ISI Insomnia Severity Index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PSQI Pittsburgh Sleep Quality Index scale score >6 and <18
- •ISI Insomnia Severity Index scale score >8 and <23
排除标准
- •People who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
- •people whose daily diet is too light or too oily are not recommended to participate in the test; people with special dietary structure (e.g. ketogenic diet, etc.) caused by weight loss or other reasons, such as muscle gain and fat loss, are not recommended to participate in the test;
- •others with special conditions are not recommended to participate, such as those who are allergic to probiotic products;
- •pregnant women, lactating women and people under 19 and over 45 years old should not experiment;
- •people with unhealthy stomach and intestines are not recommended to participate in the test;
- •people with low body fat and BMI <23 are not recommended to participate in the test.
结局指标
主要结局
intestinal flora test
时间窗: 4 weeks
Subjects took a packet of probiotics every day. Before taking probiotics, two weeks after taking probiotics, and after taking probiotics, fecal samples were collected, and fecal 16s rRNA was extracted using a DNA kit.
次要结局
未报告次要终点