Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers

Conditions
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Stress

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Administrative staff of JARLLYTEC CO., LTD. Age 20-65 years old Those who feel that they are in a medium to high stress situation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS23<br>2 capsule daily | Dietary Supplement: Probiotics<br>* Participants will be taking 2 capsule a day for 6 weeks<br>|
| Placebo Comparator: Placebo<br>2 capsule daily | Dietary Supplement: Probiotics<br>* Participants will be taking 2 capsule a day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale, PSS | 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. | From Baseline to 6 Weeks Assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index, ISI | The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome. The minimum total score possible is 0 and the maximum total score possible is 28. Higher values represent a worse outcome. | From Baseline to 6 Weeks Assessed | 
| The State-Trait Anxiety Inventory, STAI | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). The minimum total score possible is 40 and the maximum total score possible is 160. Higher scores indicate greater anxiety. | From Baseline to 6 Weeks Assessed | 
| Patient Health Questionnaire, PHQ-9 | Measure for Major Depressive Disorder from questionnaire responses, clinically significant depression defined as a PHQ-9 score of equal to or greater than 10. | From Baseline to 6 Weeks Assessed | 
| The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form-16, QLESQ-16 | The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life. The minimum total score possible is 14 and the maximum total score possible is 70. The higher score the better satisfaction. | From Baseline to 6 Weeks Assessed | 
| VAS-GI | Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics. | From Baseline to 6 Weeks Assessed | 
| Brief Fatigue Inventory | Brief Fatigue Inventory（ BFI）is a nine item scale used to evaluate the intensity of fatigue and the interference of fatigue to normal activities. The classification of fatigue severity is: Mild fatigue (1-3), Moderate fatigue (4-6) and Severe fatigue (7-10). | From Baseline to 6 Weeks Assessed | 
| Patient Global Impression scales of Improvement rated by patient, PGI-C | The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. | From Baseline to 6 Weeks Assessed | 
| Saliva Cortisol | Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase your body's metabolism of glucose control your blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by your body to ensure the balance is correct. | From Baseline to 6 Weeks Assessed | 
| Saliva α-amylase | Salivary alpha-amylase activity (sAA) is often considered to be surrogate markers of sympathetic activation in response to stress. | From Baseline to 6 Weeks Assessed | 
| Saliva IgA | Secretory IgA in saliva stands in a negative correlation to the level of the experienced stress | From Baseline to 6 Weeks Assessed | 
| Saliva Lactoferrin | lactoferrin's multiple activities lie in its capacity to bind iron and to interact with the molecular and cellular components of hosts and pathogens. it can bind and sequester lipopolysaccharides, thus preventing pro-inflammatory pathway activation, sepsis and tissue damages. | From Baseline to 6 Weeks Assessed | 
| Saliva Lysozyme | Lysozyme plays a pivotal role in the prevention of bacterial infections by attacking peptidoglycan in the bacterial cell wall. | From Baseline to 6 Weeks Assessed | 
| Job Stress Scale from the Ministry of Labor | The job stress scale from Ministry of Labor is a rating tool used to gauge of stress. | From Baseline to 6 Weeks Assessed |