Well-Being, PsychologicalNCT05968209
The Impact of Probiotic Supplementation on General Well Being
A study testing Lab4P in people with Well-Being, Psychological, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Lab4P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 7. Able to continue with normal lifestyle throughout 8. Able to consent to take part in the study
Who cannot join
- Immunodeficient
- Taking probiotics or have taken within the last month
- Allergic or suspected allergy to zinc
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cwm Taf Morgannwg Health Board
Pontypridd, Mid Glamorgan, CF37 4AL
About this study
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
- Conditions
- Well-Being, Psychological
- Being tested
- Lab4P
- Keywords
- Probiotic, Well-being, Absenteeism
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Not described Receives: Dietary Supplement: Lab4P |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Change in Absenteeism
Weekly questionnaires via an app relating to any absences from work over a week period
Measured: 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)
Measured: 60 days
Secondary outcomes (1)
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
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start16 Sep 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- Welsh Ambulance Service NHS Trust, Cultech Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968209
- Sponsor's protocol ID
- proWEB
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2023
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Probiotic Supplementation on General Well Being
- ClinicalTrials.gov ID
- NCT05968209
- Acronym / sponsor ID
- proWEB
- Conditions
- Well-Being, Psychological
- Keywords
- Probiotic, Well-being, Absenteeism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- Welsh Ambulance Service NHS Trust, Cultech Ltd
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: Lab4P |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Immunodeficient
- Taking probiotics or have taken within the last month
- Allergic or suspected allergy to zinc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab4PMulti-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) | Dietary supplement | Active group |
Primary outcome
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
Change in Absenteeism
Time frame: 60 days
Weekly questionnaires via an app relating to any absences from work over a week period
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)
1 secondary outcome
Feasibility of app-based probiotic studies
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab4P in people with Well-Being, Psychological, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life changes (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.