Clinical trial NCT05826704: Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers
Official title: Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2023-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Scale, PSS
timeFrame: From Baseline to 6 Weeks Assessed
Secondary outcomes:
measure: Insomnia Severity Index, ISI
timeFrame: From Baseline to 6 Weeks Assessed
measure: The State-Trait Anxiety Inventory, STAI
timeFrame: From Baseline to 6 Weeks Assessed
measure: Patient Health Questionnaire, PHQ-9
timeFrame: From Baseline to 6 Weeks Assessed
measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form-16, QLESQ-16
timeFrame: From Baseline to 6 Weeks Assessed
measure: VAS-GI
timeFrame: From Baseline to 6 Weeks Assessed
measure: Brief Fatigue Inventory
timeFrame: From Baseline to 6 Weeks Assessed
measure: Patient Global Impression scales of Improvement rated by patient, PGI-C
timeFrame: From Baseline to 6 Weeks Assessed
measure: Saliva Cortisol
timeFrame: From Baseline to 6 Weeks Assessed
measure: Saliva α-amylase
timeFrame: From Baseline to 6 Weeks Assessed
measure: Saliva IgA
timeFrame: From Baseline to 6 Weeks Assessed
measure: Saliva Lactoferrin
timeFrame: From Baseline to 6 Weeks Assessed
measure: Saliva Lysozyme
timeFrame: From Baseline to 6 Weeks Assessed
measure: Job Stress Scale from the Ministry of Labor
timeFrame: From Baseline to 6 Weeks Assessed
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References: