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

Study Overview

• Status: Completed
• Conditions: Well-Being, Psychological
• Intervention / Treatment: Dietary supplement: Lab4P

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Mid Glamorgan
    • Pontypridd, Mid Glamorgan, United Kingdom, CF37 4AL
      • Cwm Taf Morgannwg Health Board

Participation Criteria

Eligibility Criteria

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

Description

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

7. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group	Dietary supplement: Lab4P; Multi-strain Probiotic Product: Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Lactobacillus plantarum CUL-66, Bifidobacterium bifidum CUL-20, Bifidobacterium animalis subsp lactis CUL-34 (total 50 billion bacteria), Vitamin D (400 IU), Vitamin C (80 mg) & Zinc (10 mg)

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: Cwm Taf University Health Board (NHS)
• Collaborators: Cultech Ltd; Welsh Ambulance Service NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

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): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

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
• product manufactured in and exported from the U.S.: No