xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968209</url>
    </required_header>
    <id_info>
      <org_study_id>proWEB</org_study_id>
      <nct_id>NCT05968209</nct_id>
    </id_info>
    <brief_title>The Impact of Probiotic Supplementation on General Well Being</brief_title>
    <official_title>The Impact of Probiotic Supplementation on General Well Being</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cultech Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cwm Taff Morgannwg University Health Board</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Welsh Ambuance services Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cultech Ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The health and wellbeing of any workforce is a core priority and taking steps to ensure the&#xD;
        wellbeing of employees is an important part of everyday working life. Winter is a time of&#xD;
        particular challenge and is linked to increased absenteeism. There is a growing awareness&#xD;
        that probiotics (similar to the bacteria found in yogurts) can play a role in boosting&#xD;
        general wellbeing. Probiotics are known as 'good' or 'friendly' bacteria and are living&#xD;
        organisms that are found naturally in yogurt and fermented foods. They can be capsules,&#xD;
        tablets or powders in sachets that are taken daily to help to keep the gut in peak condition.&#xD;
        Everyone has trillions of bacteria in their guts living together happily and they are needed&#xD;
        to boost our wellbeing but the stresses and strains of everyday life can often disturb their&#xD;
        balance, probiotics can help to restore the balance. Over the winter of 2022, a small&#xD;
        exploratory study with employees based in South Wales who were offered the opportunity to&#xD;
        'try out' a probiotic manufactured by Cultech Limited (a company based in Port Talbot&#xD;
        specialising in the production of nutritional supplements). The results were very promising&#xD;
        with significant improvements in wellbeing and reduced absenteeism among those who opted to&#xD;
        take the product. This project is designed as a follow-up on last year's exploratory study by&#xD;
        including a placebo version alongside the probiotic and introduce a randomisation process to&#xD;
        assess the effectiveness of the same probiotic nutritional supplement over the winter&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of Life changes</measure>
      <time_frame>60 days</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Absenteeism</measure>
      <time_frame>60 days</time_frame>
      <description>Weekly questionnaires via an app relating to any absences from work over a week period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in gut symptoms and overall health</measure>
      <time_frame>60 days</time_frame>
      <description>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)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility of app-based probiotic studies</measure>
      <time_frame>60 days</time_frame>
      <description>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.&#xD;
  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</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Well-Being, Psychological</condition>
    <arm_group>
      <arm_group_label>Active group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Lab4P</intervention_name>
      <description>Probiotic containing:&#xD;
  Lactobacillus acidophilus - CUL 60 Lactobacillus acidophilus - CUL 21 Bifidobacterium bifidum - CUL 20 Bifidobacterium animalis subsp. lactis - CUL34 Lactobacillus plantarum - CUL 66</description>
      <arm_group_label>Active group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or Female adults aged 18-60&#xD;
  &#xD;
            2. Working in a healthcare setting&#xD;
  &#xD;
            3. Willing to use personal smartphone to access the Trialflare app and record data&#xD;
               securely and anonymously on the app during the trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Immunodeficiency/immunosuppressive therapy ongoing&#xD;
  &#xD;
            2. Pregnant or planning pregnancy&#xD;
  &#xD;
            3. Consumed probiotics regularly during the last month&#xD;
  &#xD;
            4. Taken oral antibiotics in the last month&#xD;
  &#xD;
            5. Taking part in any other research or clinical trials&#xD;
  &#xD;
            6. Colour vision deficiency&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Probiotic</keyword>
    <keyword>Well-being</keyword>
    <keyword>Absenteeism</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968209
  org study id: proWEB
  nct id: NCT05968209
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Quality of Life changes
  time frame: 60 days
  description: 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
  measure: Change in Absenteeism
  time frame: 60 days
  description: Weekly questionnaires via an app relating to any absences from work over a week period
  measure: Changes in gut symptoms and overall health
  time frame: 60 days
  description: 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)
  measure: Feasibility of app-based probiotic studies
  time frame: 60 days
  description: 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
  arm group label: Active group
  arm group type: Active Comparator
  arm group label: Placebo Group
  arm group type: Placebo Comparator
  intervention type: Dietary Supplement
  intervention name: Lab4P
  description: Probiotic containing:
  Lactobacillus acidophilus - CUL 60 Lactobacillus acidophilus - CUL 21 Bifidobacterium bifidum - CUL 20 Bifidobacterium animalis subsp. lactis - CUL34 Lactobacillus plantarum - CUL 66
  arm group label: Active group
  intervention type: Other
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor