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

Not Applicable

Terminated

• Conditions: Stress
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT05826704
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2022-12-30
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Administrative staff of JARLLYTEC CO., LTD.
2. Age 20-65 years old
3. Those who feel that they are in a medium to high stress situation

Read More

Exclusion Criteria

1. Have taken antibiotics within one month or are receiving antibiotic treatment
2. Have taken probiotic products within two weeks (excluding yogurt, yogurt, Yakult and other related foods)
3. have a history of cancer
4. Those who are allergic to lactic acid bacteria products
5. Those who are currently taking medication for acute illness, mental illness or sleep disorder
6. Pregnant or breastfeeding
7. The project host judges that it is not suitable to participate in the researcher

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PS23	Probiotics	2 capsule daily
Placebo	Probiotics	2 capsule daily

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale, PSS	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.

Secondary Outcome Measures

Name	Time	Method
The State-Trait Anxiety Inventory, STAI	From Baseline to 6 Weeks Assessed	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.
Insomnia Severity Index, ISI	From Baseline to 6 Weeks Assessed	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.
Patient Global Impression scales of Improvement rated by patient, PGI-C	From Baseline to 6 Weeks Assessed	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.
Saliva IgA	From Baseline to 6 Weeks Assessed	Secretory IgA in saliva stands in a negative correlation to the level of the experienced stress
Saliva Lactoferrin	From Baseline to 6 Weeks Assessed	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.
Job Stress Scale from the Ministry of Labor	From Baseline to 6 Weeks Assessed	The job stress scale from Ministry of Labor is a rating tool used to gauge of stress.
Saliva Cortisol	From Baseline to 6 Weeks Assessed	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.
Saliva Lysozyme	From Baseline to 6 Weeks Assessed	Lysozyme plays a pivotal role in the prevention of bacterial infections by attacking peptidoglycan in the bacterial cell wall.
Patient Health Questionnaire, PHQ-9	From Baseline to 6 Weeks Assessed	Measure for Major Depressive Disorder from questionnaire responses, clinically significant depression defined as a PHQ-9 score of equal to or greater than 10.
Brief Fatigue Inventory	From Baseline to 6 Weeks Assessed	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).
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form-16, QLESQ-16	From Baseline to 6 Weeks Assessed	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.
VAS-GI	From Baseline to 6 Weeks Assessed	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.
Saliva α-amylase	From Baseline to 6 Weeks Assessed	Salivary alpha-amylase activity (sAA) is often considered to be surrogate markers of sympathetic activation in response to stress.

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan