Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers

NCT05826704 | Terminated

• 1 other identifier: 22CT044be
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 120 subjects are expected to be recruited over a 3-year period starting after IRB approval, divided into two groups of 60 subjects, receiving PS23 or placebo, and completing a 6-week trial period.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale, PSS

  The PSS scores is a rating tool used to gauge the course of stress. The minimum total score possible is 0 and the maximum total score possible is 56. Higher values represent a worse outcome.

  From Baseline to 6 Weeks Assessed

Secondary Outcomes (13)

• Insomnia Severity Index, ISI

  From Baseline to 6 Weeks Assessed

• The State-Trait Anxiety Inventory, STAI

  From Baseline to 6 Weeks Assessed

• Patient Health Questionnaire, PHQ-9

  From Baseline to 6 Weeks Assessed

• The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form-16, QLESQ-16

  From Baseline to 6 Weeks Assessed

• VAS-GI

  From Baseline to 6 Weeks Assessed

Study Arms (2)

PS23

EXPERIMENTAL

2 capsule daily

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

2 capsule daily

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Participants will be taking 2 capsule a day for 6 weeks

PS23; Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Administrative staff of JARLLYTEC CO., LTD.
• Age 20-65 years old
• Those who feel that they are in a medium to high stress situation

You may not qualify if:

• Have taken antibiotics within one month or are receiving antibiotic treatment
• Have taken probiotic products within two weeks (excluding yogurt, yogurt, Yakult and other related foods)
• have a history of cancer
• Those who are allergic to lactic acid bacteria products
• Those who are currently taking medication for acute illness, mental illness or sleep disorder
• Pregnant or breastfeeding
• The project host judges that it is not suitable to participate in the researcher

Sponsors & Collaborators

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

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10448, Taiwan

Location

Related Publications (1)

• Wu SI, Kao KL, Lin CJ, Lin YJ, Lin IC, Chen WL. Effect of lacticaseibacillus paracasei PS23 on anxiety and sleep difficulties among office workers: a double-blind, randomized controlled pilot trial. Ann Gen Psychiatry. 2025 Oct 9;24(1):59. doi: 10.1186/s12991-025-00599-1.

  PMID: 41068940 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: December 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

TW (1)