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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826704
• Other study ID #: 22CT044be
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2023
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: December 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Stress

Intervention

Dietary Supplement:
• Probiotics
Participants will be taking 2 capsule a day for 6 weeks

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Memorial Hospital	Bened Biomedical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Saliva a-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
Secondary	Saliva IgA	Secretory IgA in saliva stands in a negative correlation to the level of the experienced stress	From Baseline to 6 Weeks Assessed
Secondary	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
Secondary	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
Secondary	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