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

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 Overview

• Status: Terminated
• Conditions: Stress
• Intervention / Treatment: Dietary supplement: Probiotics

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10448
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PS23; 2 capsule daily	Dietary supplement: Probiotics; Participants will be taking 2 capsule a day for 6 weeks
Placebo Comparator: Placebo; 2 capsule daily	Dietary supplement: Probiotics; Participants will be taking 2 capsule a day for 6 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: Bened Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22CT044be

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No