Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale, PSS
研究概览
简要总结
A total of 120 subjects are expected to be recruited over a 3-year period starting after IRB approval, divided into two groups of 60 subjects, receiving PS23 or placebo, and completing a 6-week trial period.
详细描述
There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota and further affect its relationship with sleep, inflammation, and anti-oxidation, and further studies are still needed to confirm the clinical effect. A total of 120 subjects are expected to be recruited over a 3-year period starting after IRB approval, divided into two groups of 60 subjects, receiving PS23 or placebo, and completing a 6-week trial period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Administrative staff of JARLLYTEC CO., LTD.
- •Age 20-65 years old
- •Those who feel that they are in a medium to high stress situation
排除标准
- •Have taken antibiotics within one month or are receiving antibiotic treatment
- •Have taken probiotic products within two weeks (excluding yogurt, yogurt, Yakult and other related foods)
- •have a history of cancer
- •Those who are allergic to lactic acid bacteria products
- •Those who are currently taking medication for acute illness, mental illness or sleep disorder
- •Pregnant or breastfeeding
- •The project host judges that it is not suitable to participate in the researcher
结局指标
主要结局
Perceived Stress Scale, PSS
时间窗: From Baseline to 6 Weeks Assessed
The PSS scores is a rating tool used to gauge the course of stress. The minimum total score possible is 0 and the maximum total score possible is 56. Higher values represent a worse outcome.
次要结局
- The State-Trait Anxiety Inventory, STAI(From Baseline to 6 Weeks Assessed)
- Insomnia Severity Index, ISI(From Baseline to 6 Weeks Assessed)
- Patient Global Impression scales of Improvement rated by patient, PGI-C(From Baseline to 6 Weeks Assessed)
- Saliva IgA(From Baseline to 6 Weeks Assessed)
- Saliva Lactoferrin(From Baseline to 6 Weeks Assessed)
- Patient Health Questionnaire, PHQ-9(From Baseline to 6 Weeks Assessed)
- Saliva Cortisol(From Baseline to 6 Weeks Assessed)
- Saliva Lysozyme(From Baseline to 6 Weeks Assessed)
- Job Stress Scale from the Ministry of Labor(From Baseline to 6 Weeks Assessed)
- Brief Fatigue Inventory(From Baseline to 6 Weeks Assessed)
- The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form-16, QLESQ-16(From Baseline to 6 Weeks Assessed)
- VAS-GI(From Baseline to 6 Weeks Assessed)
- Saliva α-amylase(From Baseline to 6 Weeks Assessed)