Stool Sample Collection for Research Using the In-vitro QIB Colon Model
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of 16S rDNA gene (%)
研究概览
简要总结
The aim of this project is to establish a list of volunteers willing and able to donate stool samples for use in the model colon so as to facilitate research directed toward understanding the basic science underlying the interactions between the gut microbiome, potential external modifiers, and health.
详细描述
Adult volunteers will be recruited to donate stool samples for laboratory-based experiments. Once the sample has arrived at QIB 50-100g will be added to the colon model and, depending on the system used, either cultured for 24h or for up to 40 days. During this time, factors under investigation will be added to the model.
Samples added mimic food chyme arriving at the ileal-caecal valve in the intestinal tract. At this stage digested, but non-absorbed food components plus cells and mucous shed from the lining of the small intestine enter the large intestine. Samples of bacteria and media can be taken at any point during the incubation.
Four models are used:
- a simple batch culture in which bacteria, media and test compounds are added to a single compartment and analysed over 24h
- a three compartment model with continuous flow of media, test compounds and bacteria from the entrance port of the first chamber to the exit of the third chamber mimicking movement through the three main compartments of the colon. This model allows for a stable bacterial population to be established before addition of test compounds, and can remain viable for up to 40 days. In the case of these longer incubations, multiple time points can allow for quite complex experiments looking at interactions between bacteria, food and pharmaceutical products where different factors are added at different time points.
3. a 24-well cassette-based fermenter system (Micro-Matrix Bioreactor) 4. a dynamic model SHIME (Simulator of the Human Intestinal Microbial Ecosystem) (Figure 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Live or work within 10 miles of the Norwich Research Park.
- •Having a normal bowel habit; assessed as regular defecation between 3 times a day and 3 times a week, with a form similar to 3-5 on the Bristol Stool Chart.
- •Do not have any diagnosed chronic gastrointestinal health problem, such as irritable bowel syndrome, inflammatory bowel disease, or coeliac disease.
排除标准
- •This will depend on individual experiments but in most cases samples will not be collected from individuals:
- •who have used antibiotics or probiotics in the last 2 months.
- •who are pregnant or breast feeding.
- •who have recently used other medications or food supplements (considered on a study-specific basis).
- •who have recently had an operation requiring general anaesthetic.
- •who have had a gastrointestinal upset, such as vomiting or diarrhoea within the last 72hrs.
研究组 & 干预措施
Experimental arm
Stool sample collection: Stool samples collected from study participants will be introduced into the colon model to enhance our understanding of the colonic bacterial ecosystem in response to various food components, drugs or biological therapies, and/or to allow investigation the impact of the bacterial ecosystem itself on these added components
干预措施: Stool sample collection (Other)
结局指标
主要结局
Measurement of 16S rDNA gene (%)
时间窗: Across an initial period of ten years
Measurement of 16S rDNA gene in human stool samples will reflect the bacterial population of the colon.
次要结局
- Methane concentration (mmol/L)(Across an initial period of ten years)
- Concentration of short chain fatty acids (mM)(Across an initial period of ten years)
- Glucosinolate concentration (mM)(Across an initial period of ten years)
- Fiber concentration (mM)(Across an initial period of ten years)