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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
50
Participants will be taking 2 capsule a day for 6 weeks
Mackay Memorial Hospital
Taipei, Taiwan
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.
Time frame: From Baseline to 6 Weeks Assessed
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to 6 Weeks Assessed
VAS-GI
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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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to 6 Weeks Assessed
Saliva IgA
Secretory IgA in saliva stands in a negative correlation to the level of the experienced stress
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to 6 Weeks Assessed