NCT05968209

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

July 12, 2023

Last Update Submit

April 16, 2025

Conditions

Well-Being, Psychological

Keywords

ProbioticWell-beingAbsenteeism

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Feasibility of app-based probiotic studies

    60 days

Study Arms (1)

Active group

EXPERIMENTAL
Dietary Supplement: Lab4P

Interventions

Lab4PDIETARY_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)

Active group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cwm Taf Morgannwg Health Board

Pontypridd, Mid Glamorgan, CF37 4AL, United Kingdom

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 1, 2023

Study Start

September 16, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations

GB(1)