Clinical trial NCT06381479: Exploring the Effects of Probiotics on Workplace Related Stress Symptoms
Official title: Exploring the Effects of Probiotics on Workplace Related Stress Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Sleep Disorder
Keywords: probiotics
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2024-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period.

Detailed description: This is a double blind, randomized control study, which will be conducted by National Taiwan Sport University. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. Volunteers will be asked to fill in the Perceived Stress Scale questionnaire before recruiting. Subjects who meet the criteria will be asked to fill the different questionnaires to evaluate their stress, emotions, gastrointestinal tract symptoms, sleep status and blood draw is also needed.

Eligibility criteria: Inclusion Criteria:

* Age 20 to 60 years old
* Perceived Stress Scale (PSS) score is greater than or equal to 14 points

Exclusion Criteria:

* Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
* Those who are taking Chinese medicine or Western medicine to treat severe acute diseases
* Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
* Pregnant or breastfeeding
* Those who have participated in other interventional clinical studies in the past three months
* Who has conflict of interest with PI or unsuitable to participate in the research such as students directly supervised by the project host and those who are unable to read the consent form

Primary outcomes:
measure: Cortisol
timeFrame: From Baseline to 8 Weeks Assessed
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: From Baseline to 8 Weeks Assessed
measure: Job Stress Scale
timeFrame: From Baseline to 8 Weeks Assessed
measure: Overwork Survey
timeFrame: From Baseline to 8 Weeks Assessed
measure: Insomnia Severity index (ISI)
timeFrame: From Baseline to 8 Weeks Assessed
measure: The State Trait Anxiety Inventory (STAI)
timeFrame: From Baseline to 8 Weeks Assessed
measure: Depression Anxiety Stress Scales (DASS-42)
timeFrame: From Baseline to 8 Weeks Assessed
measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
timeFrame: From Baseline to 8 Weeks Assessed
measure: VAS-GI
timeFrame: From Baseline to 8 Weeks Assessed
measure: Patient Global Impression scales of Improvement rated by patient, PGI-C
timeFrame: From Baseline to 8 Weeks Assessed
measure: Serotonin
timeFrame: From Baseline to 8 Weeks Assessed
measure: GABA
timeFrame: From Baseline to 8 Weeks Assessed
measure: Norepinephrine
timeFrame: From Baseline to 8 Weeks Assessed
measure: Immunoglobulin A, IgA
timeFrame: From Baseline to 8 Weeks Assessed
measure: adrenocorticotropic hormone, ACTH
timeFrame: From Baseline to 8 Weeks Assessed
measure: Total Antioxidant Capacity , TAC
timeFrame: From Baseline to 8 Weeks Assessed
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Graduate Institute of Sports Science, National Taiwan Sport University
Study officials:
References: