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Completed

NCT Number: NCT05968209

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cwm Taf Morgannwg Health Board

Pontypridd, Mid Glamorgan, CF37 4AL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 - 60 (at the time of consent)
  • Working in an NHS healthcare setting
  • Willing to use the Trialflare app on personal phone to record data securely
  • Able to understand and communicate using the English language
  • Normal or corrected to normal vision 6 Happy to take no other probiotics during study
  • Able to continue with normal lifestyle throughout 8. Able to consent to take part in the study

Exclusion criteria

  • Immunodeficient
  • Taking probiotics or have taken within the last month
  • Allergic or suspected allergy to zinc

Treatment and study plan

Lab4P

Dietary Supplement

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)

Primary outcomes

  1. Quality of Life changes

    Time frame: 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

  2. Change in Absenteeism

    Time frame: 60 days

    Weekly questionnaires via an app relating to any absences from work over a week period

  3. Changes in gut symptoms and overall health

    Time frame: 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)

Secondary outcomes

  1. Feasibility of app-based probiotic studies

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cwm Taf University Health Board (NHS)

Other Gov

Collaborators

  • Cultech Ltd
  • Welsh Ambulance Service NHS Trust

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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