StressNCT05826704
Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers
A study testing Probiotics in people with Stress, run by Mackay Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Administrative staff of JARLLYTEC CO., LTD.
- Age 20-65 years old
- Those who feel that they are in a medium to high stress situation
Who cannot join
- Have taken antibiotics within one month or are receiving antibiotic treatment
- Have taken probiotic products within two weeks (excluding yogurt, yogurt, Yakult and other related foods)
- have a history of cancer
- Those who are allergic to lactic acid bacteria products
- Those who are currently taking medication for acute illness, mental illness or sleep disorder
- Pregnant or breastfeeding
- The project host judges that it is not suitable to participate in the researcher
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Participants will be taking 2 capsule a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| PS23 | Experimental | 2 capsule daily Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | 2 capsule daily Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to 6 Weeks Assessed
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to 6 Weeks Assessed
Saliva IgA
Secretory IgA in saliva stands in a negative correlation to the level of the experienced stress
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to 6 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start30 Dec 2022
- Primary completion31 Dec 2023
- Study completion30 Apr 2024
Why it stopped: The company had to re-decorate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826704
- Sponsor's protocol ID
- 22CT044be
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu SI, Kao KL, Lin CJ, Lin YJ, Lin IC, Chen WL. Effect of lacticaseibacillus paracasei PS23 on anxiety and sleep difficulties among office workers: a double-blind, randomized controlled pilot trial. Ann Gen Psychiatry. 2025 Oct 9;24(1):59. doi: 10.1186/s12991-025-00599-1.
PubMed 41068940
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers
- ClinicalTrials.gov ID
- NCT05826704
- Acronym / sponsor ID
- 22CT044be
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The company had to re-decorate
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS23 | Experimental | Dietary Supplement: Probiotics2 capsule daily |
| Placebo | Placebo comparator | Dietary Supplement: Probiotics2 capsule daily |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Administrative staff of JARLLYTEC CO., LTD.
- Age 20-65 years old
- Those who feel that they are in a medium to high stress situation
Key exclusion criteria (7 listed)
- Have taken antibiotics within one month or are receiving antibiotic treatment
- Have taken probiotic products within two weeks (excluding yogurt, yogurt, Yakult and other related foods)
- have a history of cancer
- Those who are allergic to lactic acid bacteria products
- Those who are currently taking medication for acute illness, mental illness or sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsParticipants will be taking 2 capsule a day for 6 weeks | Dietary supplement | PS23, Placebo |
Primary outcome
Perceived Stress Scale, PSS
Time frame: 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.
13 secondary outcomes
Insomnia Severity Index, ISI
Time frame: From Baseline to 6 Weeks Assessed
The State-Trait Anxiety Inventory, STAI
Time frame: From Baseline to 6 Weeks Assessed
Patient Health Questionnaire, PHQ-9
Time frame: From Baseline to 6 Weeks Assessed
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form-16, QLESQ-16
Time frame: From Baseline to 6 Weeks Assessed
VAS-GI
Time frame: From Baseline to 6 Weeks Assessed
Brief Fatigue Inventory
Time frame: From Baseline to 6 Weeks Assessed
Patient Global Impression scales of Improvement rated by patient, PGI-C
Time frame: From Baseline to 6 Weeks Assessed
Saliva Cortisol
Time frame: From Baseline to 6 Weeks Assessed
Saliva α-amylase
Time frame: From Baseline to 6 Weeks Assessed
Saliva IgA
Time frame: From Baseline to 6 Weeks Assessed
Saliva Lactoferrin
Time frame: From Baseline to 6 Weeks Assessed
Saliva Lysozyme
Time frame: From Baseline to 6 Weeks Assessed
Job Stress Scale from the Ministry of Labor
Time frame: From Baseline to 6 Weeks Assessed
Results and safety
The study was stopped early (reason given: The company had to re-decorate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 41068940Wu SI, Kao KL, Lin CJ, Lin YJ, Lin IC, Chen WL. Effect of lacticaseibacillus paracasei PS23 on anxiety and sleep difficulties among office workers: a double-blind, randomized controlled pilot trial. Ann Gen Psychiatry. 2025 Oct 9;24(1):59. doi: 10.1186/s12991-025-00599-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Stress, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The company had to re-decorate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale, PSS (time frame: From Baseline to 6 Weeks Assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05826704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.