The Impact of Probiotic Supplementation on General Well Being

NCT ID: NCT05968209

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2025-04-15

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

Conditions

Well-Being, Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Active group

Group Type: EXPERIMENTAL

Lab4P

Intervention Type: 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)

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Welsh Ambulance Service NHS Trust

UNKNOWN

Sponsor Role: collaborator

Cultech Ltd

INDUSTRY

Sponsor Role: collaborator

Cwm Taf University Health Board (NHS)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cwm Taf Morgannwg Health Board

Pontypridd, Mid Glamorgan, United Kingdom

Countries

United Kingdom

Other Identifiers

proWEB

Identifier Type: -

Identifier Source: org_study_id