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

NCT04452253 | Completed

• 1 other identifier: 19CT013be
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress Scale (PSS) Score From Baseline to Change in Perceived Stress Scale (PSS) From Baseline to Week 12 Assessed for both sub-projects

  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.

  From Baseline to 8 Weeks Assessed

Secondary Outcomes (17)

• Differences in the Job Stress Scale from the Ministry of Labor before and after consumption of probiotics.

  From Baseline to 8 Weeks Assessed

• Differences in Insomnia Severity index (ISI) before and after consumption of probiotics for both sub-projects.

  From Baseline to 8 Weeks Assessed

• Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics for both sub-projects.

  From Baseline to 8 Weeks Assessed

• Differences in the The Profile of Mood States (POMS) before and after probiotics consumption for both sub-projects‧

  From Baseline to 8 Weeks Assessed

• Changes in blood TAC (Total Antioxidant Capacity) before and after consumption of probiotics for sub-project 1.

  From Baseline to 8 Weeks Assessed

Study Arms (4)

PS128

EXPERIMENTAL

The PS128, which belongs to Lactobacillus plantarum subsp. plantarum, 2 caps daily use and used in both sub-project 1 and 2. Sub-project 2 (Open label) for IT specialists only take PS128.

Dietary Supplement: PS128

PS23 live

EXPERIMENTAL

The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use, only used in sub-project 1.

Dietary Supplement: PS23 live

PS23 heat-treated

EXPERIMENTAL

PS23 heat-treated, 2 caps daily use, only used in sub-project 1.

Dietary Supplement: PS23 heat-treated

Placebo

PLACEBO COMPARATOR

The placebo capsule contains microcrystalline cellulose, 2 caps daily use, only used in sub-project 1.

Other: Placebo

Interventions

PS128 DIETARY_SUPPLEMENT

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

PS128

PS23 live DIETARY_SUPPLEMENT

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

PS23 live

PS23 heat-treated DIETARY_SUPPLEMENT

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

PS23 heat-treated

Placebo OTHER

The placebo capsule contains microcrystalline cellulose.

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Full-time nursing staff from Mackay Memorial Hospital, including wards and special units.
• Age 20 to 60 years old.
• Perceived Stress Scale (PSS) 10- questions version, with a cutoff point of 27 points or more.

You may not qualify if:

• Have taken or are receiving antibiotics within one month.
• Probiotics used in powder, capsule or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods)
• Patients with hepatobiliary gastrointestinal tract who have undergone surgery
• Patients with past or present inflammatory bowel disease
• Those with a history of cancer
• Those who are allergic to lactic acid bacteria
• Currently taking medication to treat acute or chronic diseases or sleep disorders
• Sub-project 2
• Age 20 to 60 years old.
• Perceived Stress Scale (PSS) 10- questions version, with a cutoff point of 27 points or more
• Full time employee
• Have taken or are receiving antibiotics within one month.
• Probiotics used in powder, capsule or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods)
• Patients with hepatobiliary gastrointestinal tract who have undergone surgery
• Patients with past or present inflammatory bowel disease

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10448, Taiwan

Location

Related Publications (2)

• Wu SI, Wu CC, Cheng LH, Noble SW, Liu CJ, Lee YH, Lin CJ, Hsu CC, Chen WL, Tsai PJ, Kuo PH, Tsai YC. Psychobiotic supplementation of HK-PS23 improves anxiety in highly stressed clinical nurses: a double-blind randomized placebo-controlled study. Food Funct. 2022 Aug 30;13(17):8907-8919. doi: 10.1039/d2fo01156e.

  PMID: 35924970 DERIVED

• Wu SI, Wu CC, Tsai PJ, Cheng LH, Hsu CC, Shan IK, Chan PY, Lin TW, Ko CJ, Chen WL, Tsai YC. Psychobiotic Supplementation of PS128TM Improves Stress, Anxiety, and Insomnia in Highly Stressed Information Technology Specialists: A Pilot Study. Front Nutr. 2021 Mar 26;8:614105. doi: 10.3389/fnut.2021.614105. eCollection 2021.

  PMID: 33842519 DERIVED

Study Officials

• Ying-Chieh Tsai, Ph.D

  Bened Biomedical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Physician

Model Details: Sub-project 1 is a RCT study (Nurses) Sub-project 2 is an open label design (IT Employees)

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 30, 2020
• Study Start: August 6, 2019
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

TW (1)