Networks of Bacterium-Metabolite Interactions in the Small Intestine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Identification of stimulating and inhibiting metabolite and bacteria interactions
研究概览
简要总结
Probands with an Ileo- or Colostomy are assigned to consume a test meal which is either high in fat or high in carbohydrates. After the test meal samples from the stoma, urine, blood and skin are retrieved. These will be subjected to large scale analyses of microbiota and metabolite content. To get a better comparability test subjects will consume a standardized liquid diet three days before the study day.
详细描述
Between both study days a two week wash out phase will be done. During the study day sampling will be done at set time points until 8 hours after the consumption of the test meal.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •General good health
- •Ileostomy or colostomy
排除标准
- •Hematologic disorders with contraindication of blood draw
- •Participation in other clinical trial interfering with study protocol
结局指标
主要结局
Identification of stimulating and inhibiting metabolite and bacteria interactions
时间窗: 8 hours
Correlation of results of secondary outcome measures to find interactions
Reproduction of metabolite-bacteria interactions in vitro culture
时间窗: 2 weeks
By culturing of bacteria with possible interactions together in vitro
次要结局
- Metabolite composition in blood(8 hours)
- Metabolite composition in urine(8 hours)
- Metabolite composition in intestinal fluids, blood and urine(8 hours)
- Analysis of bacteria species composition(8 hours)
- Analyze eucaryotic and viral microbiome composition(8 hours)
- Analysis of microbiota metabolic potential(8 hours)
- Cultivation of bacterial strains in various conditions including ileal fluids(2 weeks)
- Analysis of microbiota metabolic activity(8 hours)
- Metabolite composition in intestinal fluids(8 hours)
- Analysis of microbiota biomass(8 hours)