Probiotics Clinical Trial
Official title:
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
NCT number | NCT04452253 |
Other study ID # | 19CT013be |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 6, 2019 |
Est. completion date | June 18, 2021 |
Verified date | December 2022 |
Source | Mackay Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | June 18, 2021 |
Est. primary completion date | June 18, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Sub-project 1 Inclusion Criteria: - 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. Exclusion Criteria: - 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 Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital | Bened Biomedical Co., Ltd. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Differences in the Job Stress Scale from the Ministry of Labor before and after consumption of probiotics. | The job stress scale from Ministry of Labor is a rating tool used to gauge of stress. | From Baseline to 8 Weeks Assessed | |
Secondary | Differences in Insomnia Severity index (ISI) before and after consumption of probiotics for both sub-projects. | The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome. | From Baseline to 8 Weeks Assessed | |
Secondary | Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics for both sub-projects. | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. | From Baseline to 8 Weeks Assessed | |
Secondary | Differences in the The Profile of Mood States (POMS) before and after probiotics consumption for both sub-projects? | The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in blood TAC (Total Antioxidant Capacity) before and after consumption of probiotics for sub-project 1. | TAC is the biomarker for Oxidative stress | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in blood DHEA-S (Dehydroepiandrosterone sulfate) before and after consumption of probiotics for sub-project 1. | DHEA-S (Dehydroepiandrosterone sulfate) is the biomarker for anti-aging,among the neuroactive steroids, dehydroepiandrosterone (3b-hydroxyandrost-5-ene-17-one, [DHEA]) and its sulfated metabolite DHEA sulfate (DHEAS) have been shown to be potent modulators of neural function, including neurogenesis, neuronal growth and differentiation, and neuroprotection. Highlighting the potential health significance of DHEA and DHEAS in humans, serum concentrations decrease steadily with age, with lowest concentrations present at the time many diseases of aging and neurodegeneration become apparent. | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in blood Cortisol before and after consumption of probiotics for sub-project 1 . Changes in saliva Cortisol before and after consumption of probiotics for sub-project 2 . | Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help:
body respond to stress or danger increase your body's metabolism of glucose control your blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by your body to ensure the balance is correct. |
From Baseline to 8 Weeks Assessed | |
Secondary | Changes in blood High sensitivity CRP (hs CRP) before and after consumption of probiotics for sub-project 1. | High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death among healthy individuals with no history of cardiovascular disease, and recurrent events and death in patients with acute or stable coronary syndromes. | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in saliva a-Amylase before and after consumption of probiotics for sub-project 2. | Salivary alpha-amylase activity (sAA) is often considered to be surrogate markers of sympathetic activation in response to stress. | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in saliva Saliva IgA before and after consumption of probiotics for sub-project 2. | Secretory IgA in saliva stands in a negative correlation to the level of the experienced stress | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in saliva lactoferrin before and after consumption of probiotics for sub-project 2. | lactoferrin's multiple activities lie in its capacity to bind iron and to interact with the molecular and cellular components of hosts and pathogens. it can bind and sequester lipopolysaccharides, thus preventing pro-inflammatory pathway activation, sepsis and tissue damages. | From Baseline to 8 Weeks Assessed | |
Secondary | Changes in saliva lysozyme before and after consumption of probiotics for sub-project 1. | Lysozyme plays a pivotal role in the prevention of bacterial infections by attacking peptidoglycan in the bacterial cell wall. | From Baseline to 8 Weeks Assessed | |
Secondary | Differences in times of deep and light sleep before and after consumption of probiotics for sub-projects 1. | Fitbit Charge 3 continuously tracks a variety of stats whenever subjects wear it. Data automatically syncs when in range of the Fitbit app throughout the day. | From one week before Baseline to 8 Weeks Assessed | |
Secondary | Differences in Trail making test before and after consumption of probiotics for sub-projects 1. | The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.[1] The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. | From Baseline to 8 Weeks Assessed | |
Secondary | Differences in Insomnia Severity Index, ISI before and after consumption of probiotics | The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. | From Baseline to 8 Weeks Assessed | |
Secondary | The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 | The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life. | From Baseline to 8 Weeks Assessed | |
Secondary | Visual Analogue Scale-GI (VAS-GI) | Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm). | From Baseline to 8 Weeks Assessed |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
Recruiting |
NCT06323642 -
Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia
|
N/A | |
Completed |
NCT03556631 -
Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
|
Phase 4 | |
Completed |
NCT04043000 -
Super 13 Pro & Prebiotics on the Human Intestinal Microflora
|
N/A | |
Completed |
NCT04289337 -
Double-blind Clinical Trials of Probiotic Products in Oral Health.
|
N/A | |
Not yet recruiting |
NCT03967301 -
Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics
|
N/A | |
Completed |
NCT02207140 -
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
|
Phase 0 | |
Completed |
NCT01201577 -
Biological Modulation of Bacterial QSSMs, Innate and Adaptive Immunity by Antibiotics, Probiotics and Prebiotics in Healthy Individuals
|
Phase 1 | |
Not yet recruiting |
NCT06063226 -
Clinical and Microbiological Aspects of Probiotics in Non-surgical Periodontal Therapy.
|
N/A | |
Recruiting |
NCT05588674 -
The Effect of Probiotics on Exercise Performance and Recovery
|
N/A | |
Completed |
NCT05798689 -
Use of a Selected Mixture of Probiotic Strains for Degrading Gluten During Digestion
|
N/A | |
Completed |
NCT03167593 -
Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.
|
Phase 2 | |
Completed |
NCT05073393 -
Effect of Probiotics on Oral Homeostasis During Sugar Stress
|
N/A | |
Completed |
NCT02971787 -
Salt Intake and Lactobacillus Abundance
|
N/A | |
Recruiting |
NCT02005003 -
Cognitive and Metabolic Effects of a Probiotic Supplement
|
N/A | |
Recruiting |
NCT05657730 -
Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults
|
N/A | |
Completed |
NCT03499184 -
Adjunctive Probiotics in Chronic Periodontitis
|
N/A | |
Enrolling by invitation |
NCT04527055 -
The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication
|
Phase 4 | |
Recruiting |
NCT05337670 -
Probiotics Regulates Skin Care in Children
|
N/A | |
Recruiting |
NCT05005611 -
Probiotics Regulates Skin Care in Children
|
N/A |