Status
Conditions
Treatments
About
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.
Full description
Sub-project 1 Materials
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:
For the sub-project 2, all the participants will complete the baseline assessment and administered with probiotics for 8 weeks.
Statistics
For the sub-project 1 our intended analysis was set a priori to analyze each probiotic vs. the placebo.
Potential Benefits:
To the patients:
It may be possible to improve the stress, sleep or gastrointestinal symptoms of high-pressure nurses by supplementing probiotics.
To the participating researchers:
All participating assessors will be able to master the interview skills after the intensive interviewer training, in particular, familiar with semi-structured psychiatric interview and a package of self-report questionnaires. The laboratory researcher will be able to master the laboratory skills of performing epigenetic analysis, which can also be helpful in extending his research experience.
Scientific expectations:
The study will fill the research gap of shift work, metabolism, and probiotics in generally healthy high stress nursing staff. The results will provide empirical evidence for Asian scientists where there is still a lack of studies linked to changes before and after protiotics intervention. The knowledge for probiotics towards health promotion is expected to be increase and hope to lead to more personalized stratification for disease-risk models and for targeting effective interventions.
Sub-project 2 Materials: 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.
Method:
IT specialists from a large IT company in Northern Taiwan were invited and first screened by the Perceived Stress Scale (PSS) 10 items version. Participants with a PSS-10 items score of 27 or higher were included in our study. Those currently under antibiotic or psychotropic treatments, have cancer, or other chronic physical or mental diseases were excluded. Two capsule that contained 300 mg of PS128TM powder, equivalent to 10 billion colony forming units, were suggested to be taken daily by the included participants. Other self-report measures included the Job Stress Scale, Visual Analogue Scale of Stress, the Insomnia Severity Index, the State and Trait Anxiety Index, The Questionnaire for Emotional Trait and State, the Patient Health Questionnaire, the Quality of Life Enjoyment and Satisfaction Questionnaire, and the Gastrointestinal Severity Index. Objective measures included Saliva levels of stress biomarkers include cortisol, α-amylase, Immunoglobulin A (IgA), lactoferrin, and lysozymes, and Tests on Attentional Performance.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Sub-project 1
Inclusion Criteria:
Exclusion Criteria:
Sub-project 2
Inclusion Criteria:
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
174 participants in 4 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal