Dietary Supplements for Reduction of Intestinal Permeability Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Zonulin levels in feces
研究概览
简要总结
A randomised and controlled trial, in which the effect of a dietary supplement is evaluated for reduction of intestinal permeability levels of subjects with high levels of zonulin in feces
详细描述
Randomized clinical trial, with masking of the statistician and the evaluator, to assess the effect of a food supplement, composed of substances that promote intestinal mucosa repair, on the levels of zonulin in feces and consequently on intestinal permeability. A control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment.
The main objective of this study is to determine if the use of a dietary supplement composed of glutamine, butyrate and lion's mane, among others, corrects the levels of zonulin in feces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml).
排除标准
- •Taking any type of antibiotic in the last month
- •Taking prebiotics or probiotics products in the last month.
- •Taking laxatives in the last month.
- •Undergoing any medicinal treatment
- •Pregnancy
- •Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.
结局指标
主要结局
Zonulin levels in feces
时间窗: 60 days
Zonulin levels in feces, assessed in ng/ml
次要结局
未报告次要终点
研究者
Isidro Fernández López
Principal investigator
Universidad Complutense de Madrid