Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2024-08-26

Brief Summary

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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.

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Detailed Description

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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

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Stress Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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probiotics

Probiotic capsules

Group Type EXPERIMENTAL

probiotics

Intervention Type DIETARY_SUPPLEMENT

each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use

placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Interventions

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probiotics

each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use

Intervention Type DIETARY_SUPPLEMENT

placebo

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes