Studying the Impact of a Low Carbohydrate Diet on the Small Intestinal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences
研究概览
简要总结
The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet.
详细描述
Additionally to stoma fluids which will be analyzed for their microbiota composition the investigators will also collect skin samples to analyze for microbiota composition and urine to analyze for metabolite composition.
Low carbohydrate diet will allow for consumption of 80g complex carbohydrates per day, simple sugars will have to be avoided completely
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Ileostomy or colostomy
- •Good general health
- •Written informed consent
排除标准
- •Major metabolic diseases that prevent adherence to low carbohydrate diet
- •Participation in other clinical trial interfering with study protocol
结局指标
主要结局
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences
时间窗: 28 days
Sample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity
次要结局
- Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)(28 days)
- Culturing of microbiota if appropriate (in vitro)(28 days)
- Analysis of microbiota biomass(28 days)
- Relative changes of total metabolite abundance in urine(28 days)
- Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing(28 days)