StressNCT06381479
Exploring the Effects of Probiotics on Workplace Related Stress Symptoms
A study testing probiotics in people with Stress and Sleep Disorder, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Sleep Disorder
- 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
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2024to 26 Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 to 60 years old
- Perceived Stress Scale (PSS) score is greater than or equal to 14 points
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, 33301
About this study
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.
Read the 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.
- Conditions
- Stress, Sleep Disorder
- Being tested
- probiotics, placebo
- Keywords
- probiotics
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use
placeboDietary supplement
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
| Study group | Role | What they receive |
|---|---|---|
| probiotics | Experimental | Probiotic capsules Receives: Dietary Supplement: probiotics |
| placebo | Placebo comparator | Placebo capsules Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 body's metabolism of glucose control 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 body to ensure the balance is correct.
Measured: From Baseline to 8 Weeks Assessed
Secondary outcomes (15)
Perceived Stress Scale (PSS)
The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome.
Measured: From Baseline to 8 Weeks Assessed
Job Stress Scale
The job stress scale from Ministry of Labor is a rating tool used to gauge of stress.
Measured: From Baseline to 8 Weeks Assessed
Overwork Survey
This survey is used as self-evaluation of whether an employee overworks, based on the Overwork Survey by Occupational Safety and Health Administration, Ministry of Labor. The survey includes personal-related overwork and work-related overwork.
Measured: From Baseline to 8 Weeks Assessed
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 8 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"). Higher scores indicate greater anxiety.
Measured: From Baseline to 8 Weeks Assessed
Depression Anxiety Stress Scales (DASS-42)
The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Measured: From Baseline to 8 Weeks Assessed
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-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 8 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 8 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 8 Weeks Assessed
Serotonin
Levels of serotonin in serum
Measured: From Baseline to 8 Weeks Assessed
GABA
Levels of GABA in serum
Measured: From Baseline to 8 Weeks Assessed
Norepinephrine
Levels of Norepinephrine in serum
Measured: From Baseline to 8 Weeks Assessed
Immunoglobulin A, IgA
Levels of Immunoglobulin A, IgA in serum
Measured: From Baseline to 8 Weeks Assessed
adrenocorticotropic hormone, ACTH
Levels of adrenocorticotropic hormone, ACTH in serum
Measured: From Baseline to 8 Weeks Assessed
Total Antioxidant Capacity , TAC
Levels of Total Antioxidant Capacity , TAC in serum
Measured: From Baseline to 8 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 2024
- Study start19 Apr 2024
- Primary completion31 Jul 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381479
- Sponsor's protocol ID
- B031
- Status last verified
- Aug 2024
- First submitted
- 19 Apr 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Probiotics on Workplace Related Stress Symptoms
- ClinicalTrials.gov ID
- NCT06381479
- Acronym / sponsor ID
- B031
- Conditions
- Stress, Sleep Disorder
- Keywords
- probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 24 Apr 2024 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics | Experimental | Dietary Supplement: probioticsProbiotic capsules |
| placebo | Placebo comparator | Dietary Supplement: placeboPlacebo capsules |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 20 to 60 years old
- Perceived Stress Scale (PSS) score is greater than or equal to 14 points
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| probioticseach capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use | Dietary supplement | probiotics |
| placeboThe placebo capsule contains microcrystalline cellulose, 2 caps daily use. | Dietary supplement | placebo |
Primary outcome
Cortisol
Time frame: From Baseline to 8 Weeks Assessed
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 body's metabolism of glucose control 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 body to ensure the balance is correct.
15 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: From Baseline to 8 Weeks Assessed
Job Stress Scale
Time frame: From Baseline to 8 Weeks Assessed
Overwork Survey
Time frame: From Baseline to 8 Weeks Assessed
Insomnia Severity index (ISI)
Time frame: From Baseline to 8 Weeks Assessed
The State Trait Anxiety Inventory (STAI)
Time frame: From Baseline to 8 Weeks Assessed
Depression Anxiety Stress Scales (DASS-42)
Time frame: From Baseline to 8 Weeks Assessed
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Time frame: From Baseline to 8 Weeks Assessed
VAS-GI
Time frame: From Baseline to 8 Weeks Assessed
Patient Global Impression scales of Improvement rated by patient, PGI-C
Time frame: From Baseline to 8 Weeks Assessed
Serotonin
Time frame: From Baseline to 8 Weeks Assessed
GABA
Time frame: From Baseline to 8 Weeks Assessed
Norepinephrine
Time frame: From Baseline to 8 Weeks Assessed
Immunoglobulin A, IgA
Time frame: From Baseline to 8 Weeks Assessed
adrenocorticotropic hormone, ACTH
Time frame: From Baseline to 8 Weeks Assessed
Total Antioxidant Capacity , TAC
Time frame: From Baseline to 8 Weeks Assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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 and Sleep Disorder, run by National Taiwan Sport University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cortisol (time frame: From Baseline to 8 Weeks Assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.