Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Characterization of gut microbiota and associated molecules in the healthy human gastrointestinal tract upon nutritional supplementation
研究概览
简要总结
This study will assess global small molecule profiles identified in the human gastrointestinal tract of healthy human volunteers.
详细描述
The gut is home to an extensive interaction between the host and its microbiota, in different regions exposed to endogenous and exogenous signals, such as nutrition, medications, immune alterations, and geographical location-related factors. this study aims to characterize the small molecule profiles of a cohort of healthy individuals, including their polar, semi-polar, non-polar, and protein landscape. The investigators will develop a pipeline enabling to integrate these small molecule profiles with a variety of inter-individual readouts, as assessed in stools of healthy volunteers. Data will be used to characterize molecular patterns potentially associated with a variety of dietary, immune, and health-related human features, with an aim to characterize small molecules for future causative investigation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal BMI
- •Age 18-70
排除标准
- •Known food allergies to the tested food items
- •Chronic constipation (less than one bowel movement every two days)
- •Chronic treatment with any drug upon enrolment.
- •The use of systemic antibiotics, probiotics, or proton pump inhibitors 3 months prior to enrollment.
- •Diagnosis of type 1 or type 2 diabetes.
- •Any chronic disease at the discretion of the study team- such as active or recent cancer, inflammatory bowel disease, systemic autoimmunity
- •Any psychiatric disorders
- •Alcohol or substance abuse
- •Gut-related surgery, including bariatric surgery, but not including previous appendectomy.
- •Pregnancy, breastfeeding, or fertility treatments 6 months prior to enrollment for female participants
结局指标
主要结局
Characterization of gut microbiota and associated molecules in the healthy human gastrointestinal tract upon nutritional supplementation
时间窗: 1 month
Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples collected during a nutritional intervention. The analysis includes - a shot-gun metagenomics, metabolomics and proteomic anlaysis. The analysis includes - proteomics, metabolomics and a shot-gun metagenomics.
次要结局
未报告次要终点
研究者
Eran Elinav
Professor Eran Elinav
Weizmann Institute of Science