Associations of Serum Total Antioxidant Capacity and Sleep or Psychiatric Symptoms in Employees Experiencing High Levels of Stress Before and After the Intake of Probiotics

Sub-project 1 Materials

1. Probiotics The probiotics used in this proposal are selected to be more related to mental conditions. The PS128, which belongs to Lactobacillus plantarum subsp. plantarum. Administration of probiotics for 4 weeks in animal experiments showed significant improvements in depression and anxiety behaviors, and increased mobility in mice (Liu et al., 2016). The concentration of dopamine in the prefrontal cortex, which was reduced due to depression, was also restored by feeding PS128 (Liu et al., 2016). PS23 belongs to Lactobacillus paracasei group. In animal experiments, both live and heat-treated bacteria have the effect of improving depression and anxiety behaviors. The strains used in this study are food usable bacteria listed on the front of the Food and Drug Administration in Taiwan. The products have been sold in Taiwan in 2015 and there have been no serious adverse reactions. Relevant clinical studies have been reviewed by Institutional Review Boards in multiple hospitals (including the National Taiwan University Children's Hospital, Kaohsiung Kai-Syuan Psychiatric Hospital, Wanfang Hospital, Antai Hospital, and National Yangming University). These probiotics and placebo will be provided by the Yifu Biomedical Company Ltd. The probiotic powder contains no lactose and can be eaten by people with lactose intolerance. The placebo capsule contains microcrystalline cellulose. 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. These products should be stored in the refrigerator and be protected from light. The probiotics and placebo used in the study are all edible fungi or food supplements approved by the Food and Drug Administration. There are no data on serious potential risks or side effects. Only a few gastric discomfort such as bloating or diarrhea have been reported.

Monitoring of adverse events and adverse reactions includes soft stools, flatulence, or diarrhea will be used for safety and tolerability assessment.

A total of 2 assessments and blood draws (week 0 and 8+1 weeks) will be required during the study period. Subjects will be invited to participate in the study (V0) and a questionnaire will be assessed. Those who meet the inclusion criteria will be assessed for baseline (V1), and the app for working hours recording and Rhythm (mobile phone schedule) must be installed to participants' mobile phones to record the working hours in the hospital. The once daily test capsules will be consumed the next day after the evaluation for 8 weeks until week 8 +1 (V2). At V2, a second assessment will be performed. The time of the second assessment needs to be the same as the first assessment. For example, the first assessment is for the day shift, and the second assessment must be for the day shift. The number of days consumed by each subject may be inconsistent, at least 28 days, and up to 35 days. Subjects are required to provide a working schedule for the study period for the second assessment to allow the investigator to match the assessment results for the analysis.

Research methods: