The Impact of Probiotic Supplementation on General Well Being

Not Applicable

Completed

• Conditions: Well-Being, Psychological
• Interventions: Dietary Supplement: Lab4P; Other: Placebo

• Registration Number: NCT05968209
• Lead Sponsor: Cwm Taf University Health Board (NHS)

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 to further assess effectiveness of the same probiotic nutritional supplement over the winter

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Study Start: 2024-09-16
• Status Verified: 2025-04
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

1. Aged 18 - 60 (at the time of consent)

2. Working in an NHS healthcare setting

3. Willing to use the Trialflare app on personal phone to record data securely

4. Able to understand and communicate using the English language

5. Normal or corrected to normal vision 6 Happy to take no other probiotics during study

6. Able to continue with normal lifestyle throughout 8. Able to consent to take part in the study

Exclusion Criteria

1. Immunodeficient
2. Taking probiotics or have taken within the last month
3. Allergic or suspected allergy to zinc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active group	Lab4P	-
Placebo Group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Absenteeism	60 days	Weekly questionnaires via an app relating to any absences from work over a week period
Changes in gut symptoms and overall health	60 days	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)
Quality of Life changes	60 days	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

Secondary Outcome Measures

Name	Time	Method
Feasibility of app-based probiotic studies	60 days	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

Trial Locations

Locations (1)

Cwm Taf Morgannwg Health Board; 🇬🇧 Pontypridd, Mid Glamorgan, United Kingdom