Psychiatric Symptoms in Employees Experiencing High Levels of Stress Before and After the Intake of Probiotics

Summary

Sub-project 1 Background:With the increasing number of shift workers required for social and economic activities, increasing prevalence of metabolic diseases has been found in this group of people. Although reasons for this include reduced physical activity owing to unfixed working hours, lack of sleep or disturbances in the circadian rhythm may also be related to the occurrences of type 2 diabetes or metabolic syndrome. The mechanism may be due to sleep deprivation induced activation of the hypothalamic- pituitary- adrenal axis (HPA axis) that affects blood glucose metabolism. The gut brain axis might adjust the HPA axis via the bottom-up pathway through vagus nerve, the neuroendocrine system, or the immune system. It is also possible that physiological or psychological stressors might influence intestinal function through the top-down pathways. Associations between microbiota and many chronic diseases, including metabolic syndrome, diabetes, obesity, neurodegenerative diseases, or mental diseases have been investigated in recent years. However, the application of using probiotics in treating sleep disorders is still lacking. The probiotics used in this proposal are selected to be more related to mental conditions. The PS128, which belongs to Lactobacillus plantarum subsp. plantarum and PS23 belongs to Lactobacillus paracasei group. Both PS128 and PS23 probiotic capsules contain 10 billion CFU (colony forming units) of PS128 or PS23. The PS23 heat-treated probiotic capsule contain 10 billion PS23 cells.

The main research hypothesis: Is it possible to develop the relevant probiotic treatment model?Our intended analysis was set a priori to analyze each probiotic vs. the placebo.

Sub-project 2 Information technology (IT) is an industry related to productions of computers, information processing, or telecommunications. Such industry highly relies on the knowledge and solutions provided by professional IT specialists. Literature has described that the subjective stress scores were higher in IT specialists that developed diabetes, hypertension, and depression. Specific probiotics, also known as psychobiotics, may have the effects of alleviating levels of stress and mood symptoms. Therefore this open-label designed, single arm, baseline-controlled trial aiming to examine whether an 8-week intervention of a novel psychobiotic Lactobacillus plantarum PS128TM (PS128TM), may improve self-perceived stress and mood symptoms among high-stress IT specialists.

Conditions

• Probiotics

Interventions

DIETARY_SUPPLEMENT

PS128

PS128 belongs to Lactobacillus plantarum subsp. plantarumand. Probiotic capsules contain 10 billion CFU (colony forming units) of PS128

DIETARY_SUPPLEMENT

PS23 live

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

DIETARY_SUPPLEMENT

PS23 heat-treated

The PS23 heat-treated probiotic capsule contain 10 billion of PS23 cells.

OTHER

Placebo

The placebo capsule contains microcrystalline cellulose.

Sponsors & Collaborators

• Bened Biomedical Co., Ltd.

  collaborator INDUSTRY

• Mackay Memorial Hospital

  lead OTHER

Principal Investigators

• Ying-Chieh Tsai, Ph.D · Bened Biomedical Co., Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-06

Primary Completion

2021-06-18

Completion

2021-06-18

Countries

• Taiwan

Study Locations