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/NCT05986955</url>
    </required_header>
    <id_info>
      <org_study_id>RES-21-0000-602A</org_study_id>
      <nct_id>NCT05986955</nct_id>
    </id_info>
    <brief_title>The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health</brief_title>
    <acronym>FIG</acronym>
    <official_title>Food Derived Bacteria and Their Role in Treating Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Monash University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Monash University</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this clinical trial is to examine the impact of food derived bacteria on gut&#xD;
        microbiome composition and host health. The main questions it aims to answer are:&#xD;
  &#xD;
          -  what is the the rate of gastrointestinal colonisation of food derived bacteria?&#xD;
  &#xD;
          -  what is the contribution of food derived bacteria to gut microbiome stability?&#xD;
  &#xD;
        Participants will complete a cross over feeding study of dietitian designed meals of known&#xD;
        microbial load and will be asked to provide stool and blood samples for analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To understand the role and stability of food derived bacteria in impacting microbiome&#xD;
        composition, 20 healthy participants will be recruited for this single site double blinded&#xD;
        randomised controlled crossover pilot trial. The study is divided into four 14 day diet&#xD;
        phases - baseline habitual, specified diet 1, habitual washout and specified diet 2.&#xD;
        Participants will be randomly assigned to receive a microbial or non-microbial diet in&#xD;
        specified diet 1 phase. Each participant will then crossover to receive the alternative diet&#xD;
        in the specified diet 2 phase. The microbial and non-microbial diets will be identical except&#xD;
        for the removal of naturally occurring food derived bacteria in non-microbial diet. At the&#xD;
        commencement of the study and at the end of each diet phase, participants will attend a&#xD;
        research clinic to undergo comprehensive clinical and anthropometric assessment and dietary&#xD;
        evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Characterisation of gut microbiome</measure>
      <time_frame>Day 1, 4, 7, 11 and 14 of each phase</time_frame>
      <description>Sequencing and bacterial culturing of stool samples</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant body mass index (BMI)</measure>
      <time_frame>BMI will be calculated on day 14 (at end of each diet phase (fortnightly))</time_frame>
      <description>Assessed independently using height and weight measurements and appropriate formula</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant standing height</measure>
      <time_frame>Height will be measured on day 14 (at end of each diet phase (fortnightly))</time_frame>
      <description>Measured by stadiometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant weight</measure>
      <time_frame>Weight will be measured on day 14 (at end of each diet phase (fortnightly))</time_frame>
      <description>Measured using balance scales</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant waist circumference</measure>
      <time_frame>Baseline day 1 and end of each 14-day diet phase</time_frame>
      <description>Measured using standard measuring tape</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant Hip circumference</measure>
      <time_frame>Baseline day 1 and end of each 14-day diet phase</time_frame>
      <description>Measured using standard measuring tape</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resting systolic and diastolic blood pressure</measure>
      <time_frame>Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))</time_frame>
      <description>Measured using digital blood pressure monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental Health Assessment</measure>
      <time_frame>Completed at day 1 and end of study (day 56)</time_frame>
      <description>Perceived Stress Scale survey completed by participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary compliance</measure>
      <time_frame>Day 1 to Day 14 of specified diet 1 and diet 2 phases</time_frame>
      <description>Measured by participant completed daily diet checklist noting the amount of food they consumed of provided meals during specific diet 1 and 2 phases</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Habitual dietary intake</measure>
      <time_frame>Daily throughout 14-day baseline habitual and habitual washout phases</time_frame>
      <description>Using research food diary mobile phone application</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in physical activity levels</measure>
      <time_frame>Completed at each of each 14-day diet phase</time_frame>
      <description>Using International Physical Activity Questionnaire - Short Form (IPAQ-SF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glucose levels</measure>
      <time_frame>Blood collected at baseline day 1 and day 14 of each phase (fortnightly)</time_frame>
      <description>Blood samples collected will be assessed for glucose levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid studies</measure>
      <time_frame>Blood collected at baseline day 1 and day 14 of each phase (fortnightly)</time_frame>
      <description>Blood samples collected will be assessed for lipid studies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)</measure>
      <time_frame>End of each 14-day diet phase</time_frame>
      <description>Completion of Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrointestinal symptomatology</measure>
      <time_frame>Baseline day 1 and day 14 of each diet phase (fortnightly)</time_frame>
      <description>Completion of Gastrointestinal Symptom Rating Scale (GSRS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bowel movement</measure>
      <time_frame>Baseline day 1 and day 14 of each diet phase (fortnightly)</time_frame>
      <description>Completion of Bristol Stool Chart questionnaires</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>End of study optional semi-structured interview</measure>
      <time_frame>End of study (at least 8 weeks post-randomisation)</time_frame>
      <description>Interview participants to assess challenges of adhering to study and compliance</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Specified Diet 1 - Microbial Diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants provided with a typical Australian diet including all food groups as described by the Australian Guide to Healthy Eating without any dietary exclusions. Meals have been designed by researchers and dietitians and prepared by professional chefs.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Specified Diet 2 - Non-microbial Diet</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Diet provided to participants is identical to Specified Diet 1 however after cooking and packaging, food for this arm will be sterilised by irradiation in line with International Organisation for Standardisation (ISO) standards and Australian code of good manufacturing practice.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diet</intervention_name>
      <description>Participants will be assigned prospectively to microbial or non-microbial diet for first phase of trial and will then cross over to the alternate diet following a washout period.</description>
      <arm_group_label>Specified Diet 1 - Microbial Diet</arm_group_label>
      <arm_group_label>Specified Diet 2 - Non-microbial Diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have no genetic conditions (e.g. Prader Willi or Down's Syndrome)&#xD;
  &#xD;
            -  Not diagnosed with a significant medical conditions (e.g. irritable bowel syndrome,&#xD;
               inflammatory bowel disease or type 1/2 diabetes)&#xD;
  &#xD;
            -  Do not require drug-therapy (e.g. steroids or insulin or antibiotics)&#xD;
  &#xD;
            -  Not taking dietary supplements, probiotics, prebiotics, symbiotics or fibre&#xD;
               supplementation&#xD;
  &#xD;
            -  Any condition that will affect participation in the study&#xD;
  &#xD;
            -  Not pregnant, planning a pregnancy or breastfeeding&#xD;
  &#xD;
            -  Able to complete a two-month dietary study and agree to eating all meals provided&#xD;
  &#xD;
            -  Have no dietary allergies or dietary restrictions that prevent consumption of provided&#xD;
               study meals&#xD;
  &#xD;
            -  Open bowels regularly - mostly daily&#xD;
  &#xD;
            -  Able to read, write and understand English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dietary concerns identified by dietitian&#xD;
  &#xD;
            -  Aged less than 18 years and older than 65 years&#xD;
  &#xD;
            -  Diagnosed with a medical condition that requires drug therapy&#xD;
  &#xD;
            -  Taking medications or supplements known to alter gastrointestinal microbiota&#xD;
  &#xD;
            -  Women who are pregnant, planning a pregnancy or breastfeeding&#xD;
  &#xD;
            -  Anyone with a diagnosed gastrointestinal condition/disease e.g. irritable bowel&#xD;
               syndrome or inflammatory bowel disease&#xD;
  &#xD;
            -  Known dietary allergy and/or intolerance, follows a vegan or vegetarian diet, or has&#xD;
               coeliac disease&#xD;
  &#xD;
            -  Anyone with a preference for specific food avoidance or exclusion of certain&#xD;
               ingredients in habitual diet&#xD;
  &#xD;
            -  Unable to tolerate blood collection procedures&#xD;
  &#xD;
            -  Unable to provide regular stool samples throughout the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dr. Sam Forster</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hudson Institue, Monash University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emma Saltzman</last_name>
      <phone>+61439035949</phone>
      <email>emma.saltzman@monash.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dr. Sam Forster</last_name>
      <phone>+61385722735</phone>
      <email>sam.forster@hudson.org.au</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Monash University</investigator_affiliation>
      <investigator_full_name>Dr. Sam Forster</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Applications made for reasonable access to de-identified study data will be made on a case-by-case basis by the study team. Data-specified appropriate analysis will be determined when required. Applications for data accessibility will be made on a case-by-case basis by study team.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Accessibility to individual participant data (IPD) and supporting information will be determined at a later date and on a case-by-case basis</ipd_time_frame>
      <ipd_access_criteria>Accessibility will be assessed on a case-by-case basis</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05986955
  org study id: RES-21-0000-602A
  nct id: NCT05986955
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to examine the impact of food derived bacteria on gut
        microbiome composition and host health. The main questions it aims to answer are:
  
          -  what is the the rate of gastrointestinal colonisation of food derived bacteria?
  
          -  what is the contribution of food derived bacteria to gut microbiome stability?
  
        Participants will complete a cross over feeding study of dietitian designed meals of known
        microbial load and will be asked to provide stool and blood samples for analysis.
  To understand the role and stability of food derived bacteria in impacting microbiome
        composition, 20 healthy participants will be recruited for this single site double blinded
        randomised controlled crossover pilot trial. The study is divided into four 14 day diet
        phases - baseline habitual, specified diet 1, habitual washout and specified diet 2.
        Participants will be randomly assigned to receive a microbial or non-microbial diet in
        specified diet 1 phase. Each participant will then crossover to receive the alternative diet
        in the specified diet 2 phase. The microbial and non-microbial diets will be identical except
        for the removal of naturally occurring food derived bacteria in non-microbial diet. At the
        commencement of the study and at the end of each diet phase, participants will attend a
        research clinic to undergo comprehensive clinical and anthropometric assessment and dietary
        evaluation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Characterisation of gut microbiome
  time frame: Day 1, 4, 7, 11 and 14 of each phase
  description: Sequencing and bacterial culturing of stool samples
  measure: Participant body mass index (BMI)
  time frame: BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
  description: Assessed independently using height and weight measurements and appropriate formula
  measure: Participant standing height
  time frame: Height will be measured on day 14 (at end of each diet phase (fortnightly))
  description: Measured by stadiometer
  measure: Participant weight
  time frame: Weight will be measured on day 14 (at end of each diet phase (fortnightly))
  description: Measured using balance scales
  measure: Participant waist circumference
  time frame: Baseline day 1 and end of each 14-day diet phase
  description: Measured using standard measuring tape
  measure: Participant Hip circumference
  time frame: Baseline day 1 and end of each 14-day diet phase
  description: Measured using standard measuring tape
  measure: Resting systolic and diastolic blood pressure
  time frame: Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))
  description: Measured using digital blood pressure monitor
  measure: Mental Health Assessment
  time frame: Completed at day 1 and end of study (day 56)
  description: Perceived Stress Scale survey completed by participants
  measure: Dietary compliance
  time frame: Day 1 to Day 14 of specified diet 1 and diet 2 phases
  description: Measured by participant completed daily diet checklist noting the amount of food they consumed of provided meals during specific diet 1 and 2 phases
  measure: Habitual dietary intake
  time frame: Daily throughout 14-day baseline habitual and habitual washout phases
  description: Using research food diary mobile phone application
  measure: Changes in physical activity levels
  time frame: Completed at each of each 14-day diet phase
  description: Using International Physical Activity Questionnaire - Short Form (IPAQ-SF)
  measure: Glucose levels
  time frame: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
  description: Blood samples collected will be assessed for glucose levels
  measure: Lipid studies
  time frame: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
  description: Blood samples collected will be assessed for lipid studies
  measure: Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
  time frame: End of each 14-day diet phase
  description: Completion of Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
  measure: Gastrointestinal symptomatology
  time frame: Baseline day 1 and day 14 of each diet phase (fortnightly)
  description: Completion of Gastrointestinal Symptom Rating Scale (GSRS)
  measure: Bowel movement
  time frame: Baseline day 1 and day 14 of each diet phase (fortnightly)
  description: Completion of Bristol Stool Chart questionnaires
  measure: End of study optional semi-structured interview
  time frame: End of study (at least 8 weeks post-randomisation)
  description: Interview participants to assess challenges of adhering to study and compliance
  arm group label: Specified Diet 1 - Microbial Diet
  arm group type: Experimental
  description: Participants provided with a typical Australian diet including all food groups as described by the Australian Guide to Healthy Eating without any dietary exclusions. Meals have been designed by researchers and dietitians and prepared by professional chefs.
  arm group label: Specified Diet 2 - Non-microbial Diet
  arm group type: Active Comparator
  description: Diet provided to participants is identical to Specified Diet 1 however after cooking and packaging, food for this arm will be sterilised by irradiation in line with International Organisation for Standardisation (ISO) standards and Australian code of good manufacturing practice.
  intervention type: Other
  intervention name: Diet
  description: Participants will be assigned prospectively to microbial or non-microbial diet for first phase of trial and will then cross over to the alternate diet following a washout period.
  arm group label: Specified Diet 1 - Microbial Diet
  arm group label: Specified Diet 2 - Non-microbial Diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dr. Sam Forster
  role: Principal Investigator
  affiliation: Hudson Institue, Monash University
  last name: Emma Saltzman
  phone: +61439035949
  email: emma.saltzman@monash.edu
  last name: Dr. Sam Forster
  phone: +61385722735
  email: sam.forster@hudson.org.au
  responsible party type: Principal Investigator
  investigator affiliation: Monash University
  investigator full name: Dr. Sam Forster
  investigator title: Principal Investigator
  sharing ipd: Yes
  ipd description: Applications made for reasonable access to de-identified study data will be made on a case-by-case basis by the study team. Data-specified appropriate analysis will be determined when required. Applications for data accessibility will be made on a case-by-case basis by study team.
  ipd info type: Study Protocol
  ipd time frame: Accessibility to individual participant data (IPD) and supporting information will be determined at a later date and on a case-by-case basis
  ipd access criteria: Accessibility will be assessed on a case-by-case basis