The Impact of Probiotic Supplementation on General Well Being

Study Overview
=================
Brief Summary
-----------------
The health and wellbeing of any workforce is a core priority and taking steps to ensure the wellbeing of employees is an important part of everyday working life. Winter is a time of particular challenge and is linked to increased absenteeism. There is a growing awareness that probiotics (similar to the bacteria found in yogurts) can play a role in boosting general wellbeing. Probiotics are known as 'good' or 'friendly' bacteria and are living organisms that are found naturally in yogurt and fermented foods. They can be capsules, tablets or powders in sachets that are taken daily to help to keep the gut in peak condition. Everyone has trillions of bacteria in their guts living together happily and they are needed to boost our wellbeing but the stresses and strains of everyday life can often disturb their balance, probiotics can help to restore the balance. Over the winter of 2022, a small exploratory study with employees based in South Wales who were offered the opportunity to 'try out' a probiotic manufactured by Cultech Limited (a company based in Port Talbot specialising in the production of nutritional supplements). The results were very promising with significant improvements in wellbeing and reduced absenteeism among those who opted to take the product. This project is designed as a follow-up on last year's exploratory study by including a placebo version alongside the probiotic and introduce a randomisation process to assess the effectiveness of the same probiotic nutritional supplement over the winter

Official Title
-----------------
The Impact of Probiotic Supplementation on General Well Being

Conditions
-----------------
Well-Being, Psychological

Intervention / Treatment
-----------------
* Dietary Supplement: Lab4P
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female adults aged 18-60 Working in a healthcare setting Willing to use personal smartphone to access the Trialflare app and record data securely and anonymously on the app during the trial Exclusion Criteria: Immunodeficiency/immunosuppressive therapy ongoing Pregnant or planning pregnancy Consumed probiotics regularly during the last month Taken oral antibiotics in the last month Taking part in any other research or clinical trials Colour vision deficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active group<br> | Dietary Supplement: Lab4P<br>* Probiotic containing: Lactobacillus acidophilus - CUL 60 Lactobacillus acidophilus - CUL 21 Bifidobacterium bifidum - CUL 20 Bifidobacterium animalis subsp. lactis - CUL34 Lactobacillus plantarum - CUL 66<br>|
| Placebo Comparator: Placebo Group<br> | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life changes | Weekly questionnaires via an app containing questions relating to the participant's quality of life (i.e. mood, sleep, energy levels) over a week period | 60 days | 
| Change in Absenteeism | Weekly questionnaires via an app relating to any absences from work over a week period | 60 days | 
| Changes in gut symptoms and overall health | Weekly questionnaires via an app containing questions on the number of days participants may have experiences gut related symptoms (i.e. bloating, constipation, diarrhoea, stomach pain), and overall health (i.e. headaches, coughs, sore thorat) | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of app-based probiotic studies | To gain an understanding of the level of interest amongst the workforce to take part in probiotic studies and use of an app to monitor well-being. Measured through levels of sign-up, collection of intervention and drop-out rate over the course of the trial. All which will be measured through the app | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic, Well-being, Absenteeism