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The Impact of Probiotic Supplementation on General Well Being

The Impact of Probiotic Supplementation on General Well Being

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05968209
Enrollment
173
Registered
2023-08-01
Start date
2024-09-16
Completion date
2025-04-15
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-Being, Psychological

Keywords

Probiotic, Well-being, Absenteeism

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

Interventions

DIETARY_SUPPLEMENTLab4P

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)

Sponsors

Welsh Ambulance Service NHS Trust
CollaboratorUNKNOWN
Cultech Ltd
CollaboratorINDUSTRY
Cwm Taf University Health Board (NHS)
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life changes60 daysWeekly questionnaires via an app containing questions relating to the participant's quality of life (i.e. mood, sleep, energy levels) over a week period
Change in Absenteeism60 daysWeekly questionnaires via an app relating to any absences from work over a week period
Changes in gut symptoms and overall health60 daysWeekly 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)

Secondary

MeasureTime frameDescription
Feasibility of app-based probiotic studies60 daysTo 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026