Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Lactulose / mannitol ratio
研究概览
简要总结
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.
详细描述
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods. In healthy volunteers potential biomarkers for intestinal permeability as well as an established "gold standard" method for intestinal permeability (urinary lactulose/mannitol excretion) will be measured at one time point. Using correlation analyses, potential associations will be assessed and potential biomarkers will be addressed and discussed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Healthy volunteers
- •Written informed consent
排除标准
- •Underweight (BMI <18 kg / m2) and obesity from grade II (BMI ≥ 30 kg / m2)
- •Acute or chronic gastrointestinal diseases
- •Chronically consuming diseases (e.g. chronic tumor disease, florid infections, etc.)
- •Smokers (12 hours before the test and during the test it is not allowed to smoke)
- •Ingestion of intestinal therapeutics, antibiotics, immunosuppressants or similar within the last 3 months
- •Simultaneous participation in another clinical study
- •Pregnancy / breastfeeding
- •Intolerance to the sugar solution
- •Occurrence of relevant diseases
- •Revocation of consent
结局指标
主要结局
Lactulose / mannitol ratio
时间窗: 1 day (Single measurement)
Urinary excretion of lactulose and mannitol
次要结局
- Fecal albumin [ng/mg](1 day (Single measurement))
- Fecal calprotectin [ng/mg](1 day (Single measurement))
- Fecal zonulin [ng/mg](1 day (Single measurement))
- Plasma lipopolysaccharide binding protein [µg/ml](1 day (Single measurement))
研究者
Stephan C. Bischoff, MD, Professor
Prof. Dr.
University of Hohenheim