The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Cognition
研究概览
简要总结
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.
详细描述
30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •able to give informed written consent
- •able to speak English
排除标准
- •having a significant acute or chronic illness
- •following a diet or taking a medication that would interfere with study objectives
- •pose a safety risk or confound the interpretation of the study results
- •evidence of immunodeficiency, bleeding disorder or coagulopathy
- •English not being participant's first language
- •colour blindness
- •dyslexia or dyscalculia
- •taking any probiotic products or antibiotics in the last 4 weeks
- •receiving any treatment involving experimental drugs
结局指标
主要结局
Change in Cognition
时间窗: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery
次要结局
- Change in the Inflammatory profile(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Change in Salivary cortisol concentrations(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Changes in Mood(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Changes in Anxiety(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Change in Electroencephalography (EEG)(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Changes in Stress levels(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
研究者
Prof Ted Dinan
Professor
University College Cork