Post-biotic Intervention for Acute Stress Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Salivary Cortisol
研究概览
简要总结
The study aims to evaluate the sub-chronic effects of colonic delivery of a post-biotic on stress response, mood state, sleep, and cognition in healthy young subjects with elevated self-reported stress levels. It is hypothesized that oral intake of the post-biotic, when released in the colonic intestinal site, leads to a blunted subjective and objective stress response after a stress induction.
详细描述
Scientific findings over the past years suggest that certain bacteria in our gastrointestinal system have an influence on our mood, although, the mechanisms are not yet well understood. One of the possibilities is that bacteria produce compounds that interact with neurons in the gut. These neurons could subsequently send signals to the brain.
This study is a proof of principle study examining the effects of a post-biotic in the distal intestinal tract (terminal ileum, colon) on stress response, mood state, sleep, and cognition. The study is expected to provide key insights in the potential of treatment strategies aimed at stimulating the colonic enteric nervous system to exert mood enhancement. It is hypothesized that interactions with the local Enteric Nervous System leading to stress reduction, mood enhancement and sleep promotion effects. The study will employ an in-person clinic visit, in addition to traditional self-reported, behavioural, and physiological outcome measures; exploratory digital health outcomes will also be included to identify novel objective mood/stress measures.
This study seeks to recruit a total of 75 healthy males (25 in each arm), between the ages of 21-30 years old (inclusive) from local community outreach in Singapore over a period 12 months. This study is a hybrid study (partially decentralized).
The total duration of participation from each participant will be 9 days (excluding, the screening and enrolment days).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 21 to 30 years
- •Perceived Stress Scale (PSS-10) score >13
- •Own and uses a smartphone that is capable to run the study applications with access to the internet
- •Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
- •Sufficient vision and hearing to complete study procedures
- •Willing to commit to the study procedures
- •Willing and able to participate and to give written informed consent All inclusion criteria will be assessed based on self-reported information during the screening visit.
排除标准
- •Past (< 6 months prior to the study) or current major neurological, psychiatric, gastrointestinal, metabolic disease or cardiovascular disease
- •Past (<1 months prior to the study) or current use of psychoactive medication, cardiovascular medication, or corticosteroids.
- •Known medical history of hypotension or currently on antihypertensive medication
- •Alcohol intake >1 units day
- •Present or past history of alcohol or drug addiction and/or recreational drug use
- •BMI <18.5 or >25 kg/m2
- •Maltodextrin allergy
- •Members of the research team or their immediate family members. An immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted All exclusion criteria will be assessed based on self-reported information during the screening call.
结局指标
主要结局
Salivary Cortisol
时间窗: Day 7 (5/day)
cortisol levels, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activation
次要结局
- Sleep Activity(Days 1-7)
- State Trait Anxiety Inventory (STAI-6)(Day 7 (2/day))
- The Brunel Mood Scale (BRUMS)(Day 7 (2/day))
- Heart Rate(Days 1-7)
研究者
Jeroen Schmitt
Senior Principal Scientist
Institute for Human Development and Potential (IHDP), Singapore