The Impact of Probiotic Supplementation on General Well Being

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

Study Overview

• Status: Not yet recruiting
• Conditions: Well-Being, Psychological
• Intervention / Treatment: Other: Placebo; Dietary supplement: Lab4P

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or Female adults aged 18-60
2. Working in a healthcare setting
3. Willing to use personal smartphone to access the Trialflare app and record data securely and anonymously on the app during the trial

Exclusion Criteria:

1. Immunodeficiency/immunosuppressive therapy ongoing
2. Pregnant or planning pregnancy
3. Consumed probiotics regularly during the last month
4. Taken oral antibiotics in the last month
5. Taking part in any other research or clinical trials
6. Colour vision deficiency

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Cultech Ltd
• Collaborators: Cwm Taff Morgannwg University Health Board; Welsh Ambuance services Trust

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Probiotic; Well-being; Absenteeism
• Other Study ID Numbers: proWEB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No