Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The gut microbiota composition
研究概览
简要总结
The goal of this intervention study is to evaluate the beneficial effect of the probiotic bacterium Bacillus coagulans in healthy volunteers. The main question it aims to answer is if the probiotic strains are modifying the microbiota composition in a beneficial way, evaluated in faecal- and saliva samples.
Primary hypothesis: The probiotic bacteria will modify the microbiota composition in faecal- and saliva samples.
Participants will consume the freeze-dried probiotic bacteria for 14 days. Before and after consumption, the participants will collect samples.
详细描述
Samples will be frozen immediately after collection and will be kept frozen until analysis at the Department of Process and Life Science Engineering, Faculty of Engineering, Lund University. For diversity measures, species identification and relative abundance of bacterial taxa, samples will be analysed by Illuminas MiSeq with the MiSeq reagent kit v3. Data will be analysed with bioinformatic pipeline QIIME2TM.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You must be 18-65 years of age.
排除标准
- •Participants must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency such as MS, type 1 diabetes, cancer or HIV.
- •Participants must not have taken antibiotics in the month before or during the study.
- •Participants must not consume other probiotic products or fermented foods during the study.
研究组 & 干预措施
Consumption of probiotics strain 5
The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 5).
干预措施: Consumption of probiotics strain 5 (Dietary Supplement)
Consumption of probiotics strain 6
The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 6).
干预措施: Consumption of probiotics strain 6 (Dietary Supplement)
结局指标
主要结局
The gut microbiota composition
时间窗: At enrollment and after 2 weeks of consumption.
Diversity index will be calculated based on the results from next generation sequencing
The gut microbiota composition
时间窗: At enrollment and after 2 weeks of consumption.
Diversity index will be calculated based on the results from next generation sequencing
次要结局
- Relative abundance(At enrollment and after 2 weeks of consumption.)