The Impact of Probiotic Supplementation on General Well Being

Cultech

Status: Not yet enrolling

Conditions: Well-Being, Psychological

Treatments: Dietary Supplement: Lab4P; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05968209

proWEB

Details and patient eligibility

About

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 by including a placebo version alongside the probiotic and introduce a randomisation process to assess the effectiveness of the same probiotic nutritional supplement over the winter

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female adults aged 18-60
2. Working in a healthcare setting
3. Willing to use personal smartphone to access the Trialflare app and record data securely and anonymously on the app during the trial

Exclusion criteria

1. Immunodeficiency/immunosuppressive therapy ongoing
2. Pregnant or planning pregnancy
3. Consumed probiotics regularly during the last month
4. Taken oral antibiotics in the last month
5. Taking part in any other research or clinical trials
6. Colour vision deficiency

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

Active group

Active Comparator group

Treatment:

Dietary Supplement: Lab4P

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo