Effects of Probiotic VSL#3 on Expression of Small Intestinal Mucosal Renin-angiotensin System and Glucose Absorption in Man - a Doubleblind, Randomized Parallel Arm Placebo Controlled Exploratory Study in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor)
研究概览
简要总结
Probiotics have become very popular and are by WHO defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host". For example, probiotics have been shown to contribute to improvements of abdominal discomfort and intestinal inflammation. The main hypothesis behind the present study is that probiotics influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II locally in the intestinal mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •healthy volunteers of both sexes
- •between 18 and 65 years of age.
- •BMI between 18-25 kg/m2
排除标准
- •Any drug abuse
- •Use of prescription medication within the previous 14 days (with the exception of contraceptives)
- •Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, oral contraceptive, abstinence)
- •In the investigator's judgement, clinically significant abnormalities at the screening examination or in the laboratory test results.
研究组 & 干预措施
VSL#3
干预措施: VSL#3 (Biological)
Inactive treatment
干预措施: Placebo (Biological)
结局指标
主要结局
The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor)
时间窗: Change from baseline in protein expressions after 2 weeks of treatment.
Mucosal biopsies from jejunum are sampled via endoscopy immediately before (baseline) and at the end of the 2 weeks treatment period. Protein expressions are assessed by western blotting and the subject acts as its own control.
次要结局
- Changes in epithelial permeability and glucose absorption capacity in vitro(Change from baseline at 2 weeks after start of treatment.)
- Change in intestinal glucose absorption capacity in-vivo(Change from baseline at 2 weeks after start of treatment.)