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临床试验/NCT05968209
NCT05968209已完成不适用

The Impact of Probiotic Supplementation on General Well Being

Cwm Taf University Health Board (NHS)2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2024年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
2
主要终点
Change in Absenteeism

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Able to consent to take part in the study

排除标准

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

结局指标

主要结局

Change in Absenteeism

时间窗: 60 days

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

Changes in gut symptoms and overall health

时间窗: 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)

Quality of Life changes

时间窗: 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

次要结局

  • Feasibility of app-based probiotic studies(60 days)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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