Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes of gastrointestinal function after probiotics use
研究概览
简要总结
The purpose of this study is to evaluate the effect of "combined probiotics" to improve the gastrointestinal function and intestinal bacteria flora
详细描述
Probiotics were known to improve gastrointestinal function before. This is a single-blind placebo control clinical study. We will perform gastrointestinal function questionnaire and collect stool as baseline data before the study (0-week). Then healthy subjects will be randomized to two groups.
Experimental: probiotics 1 pack bid for 3 weeks. Probiotics : (AB-kefir)：Lactobacillus acidophilus,Bifidobacterium longum,Lactobacillus paracasei,Lactobacillus rhamnosus,Lactobacillus fermentum,Streptococcus thermophilus,Lactobacillus helveticus,Kluyveromyces fragilis. Other components include starch,oligosaccharide,yeast powder, superior standard spice， calcium pantothenate， VitB1， VitB12， biotin and folic acid.
Placebo group: placebo 1 pack bid for 3 weeks. Placebo: Except the probiotics (AB-kefir),the other components are the same with study group.
Then gastrointestinal function questionnaire and stool collection will be performed at the end of 1st, 2nd, 3rd, and 4th weeks after starting the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people who are aged between 20 and 40 years
排除标准
- •People who use probiotics medication and food that can inhibit bacteria growth within one month before the study
- •People who have active infection
- •People who have active or chronic gastro-intestinal disease
- •People who have diarrhea within two weeks before the study
- •People who are drug or alcohol abuser
- •People who are poor compliance
研究组 & 干预措施
probiotics
1 pack bid use for 3 weeks
干预措施: probiotics (Dietary Supplement)
Placebo
placebo 1pack bid for 3 weeks
干预措施: probiotics (Dietary Supplement)
结局指标
主要结局
Changes of gastrointestinal function after probiotics use
时间窗: 28 days
Changes of gastrointestinal function, such as constipation, abdominal distension and appetite after proiotics and placebo use.
次要结局
- Changes of intestinal bacteria flora after probiotics use(28 days)