NCT04452253

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

Completed NA Last updated 7 December 2022

What this trial tests

NA trial testing PS128 in Probiotics in 174 participants. Completed in 18 June 2021.

Timeline

6 August 2019

Primary endpoint
18 June 2021

18 June 2021

Quick facts

Lead sponsor	Mackay Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	174
Start date	6 August 2019
Primary completion	18 June 2021
Estimated completion	18 June 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• PS128
• PS23 live
• PS23 heat-treated
• Placebo

Conditions studied

• Probiotics — all drugs for Probiotics →

Sponsor

Mackay Memorial Hospital

Who can join

Adults 20 to 60, any sex, with Probiotics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychobiotic Supplementation of PS128^TM Improves Stress, Anxiety, and Insomnia in Highly Stressed Information Technology Specialists: A Pilot Study.
   Wu SI, Wu CC, Tsai PJ, Cheng LH, et al · · 2021 · cited 36× · PMID 33842519 · DOI 10.3389/fnut.2021.614105
2. Does the Gut Microbial Metabolome Really Matter? The Connection between GUT Metabolome and Neurological Disorders.
   Marć MA, Jastrząb R, Mytych J. · · 2022 · cited 18× · PMID 36235622 · DOI 10.3390/nu14193967
3. Psychobiotic supplementation of HK-PS23 improves anxiety in highly stressed clinical nurses: a double-blind randomized placebo-controlled study.
   Wu SI, Wu CC, Cheng LH, Noble SW, et al · · 2022 · cited 12× · PMID 35924970 · DOI 10.1039/d2fo01156e