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/NCT05972330</url>
    </required_header>
    <id_info>
      <org_study_id>V308</org_study_id>
      <nct_id>NCT05972330</nct_id>
    </id_info>
    <brief_title>Efficacy of VRx MyBiotics Oral Lozenges</brief_title>
    <official_title>Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Viome</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Viome</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>
        This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the&#xD;
        oral microbiome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single arm, interventional trial on adults residing in the United States. The study&#xD;
        will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at&#xD;
        improving oral microbiome health according to Viome's Oral Health Score.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 26, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>None, Open Label</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Viome Oral Health Score</measure>
      <time_frame>~ 4 months</time_frame>
      <description>Increase in oral health score as measured by Viome's Oral Health Score.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">31</enrollment>
    <condition>Oral Microbiome Health</condition>
    <arm_group>
      <arm_group_label>VRx MyBiotics Oral Lozenges</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a 30 day supply of their personalized oral biotic lozenges.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>VRx MyBiotics Oral Lozenges</intervention_name>
      <description>VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.</description>
      <arm_group_label>VRx MyBiotics Oral Lozenges</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any person with a US address that is 18 years old or older&#xD;
  &#xD;
            -  Able to speak and read English&#xD;
  &#xD;
            -  Willing and able to follow the trial instructions, as described in the recruitment&#xD;
               letter&#xD;
  &#xD;
            -  Signed and dated informed consent prior to any trial-specific procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Systemic antibiotic treatment 30 days prior to enrollment or during the trial&#xD;
  &#xD;
            -  Not willing to stop sporadic use (less frequently than daily) of any mouthwash.&#xD;
  &#xD;
            -  Significant diet, supplements, or lifestyle change in the previous 1 month or next 2&#xD;
               months once enrolled&#xD;
  &#xD;
            -  Allergy to tapioca, peppermint, or sweet potato&#xD;
  &#xD;
            -  Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent&#xD;
               caries, oral cancer, etc)&#xD;
  &#xD;
            -  No dental procedures 30 days prior to enrollment or during the trial (regular&#xD;
               cleanings, bone grafts, dental implants, etc)&#xD;
  &#xD;
            -  Pregnancy or planned pregnancy&#xD;
  &#xD;
            -  Currently have cancer or undergoing cancer therapy&#xD;
  &#xD;
            -  Dentures&#xD;
  &#xD;
            -  Fewer than 20 teeth&#xD;
  &#xD;
            -  Use of at home teeth whitening products 30 days prior to enrollment or during the&#xD;
               trial&#xD;
  &#xD;
            -  Start new medications or supplements during the trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Momchilo Vuyisich</last_name>
      <role>Principal Investigator</role>
      <affiliation>Viome</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kaitlyn Sells</last_name>
      <phone>(425) 300-6933</phone>
      <email>studies@viome.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Momchilo Vuyisich</last_name>
      <phone>(425) 300-6933</phone>
      <email>studies@viome.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Viome Life Sciences</name>
        <address>
          <city>Bothell</city>
          <state>Washington</state>
          <zip>98011</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kaitlyn Sells</last_name>
        <phone>425-300-6933</phone>
        <email>studies@viome.com</email>
      </contact>
      <contact_backup>
        <last_name>Momchilo Vuyisich</last_name>
        <phone>(425) 300-6933</phone>
        <email>studies@viome.com</email>
      </contact_backup>
      <investigator>
        <last_name>Momchilo Vuyisich</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>oral health</keyword>
    <keyword>oral lozenge</keyword>
    <keyword>oral microbiome</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/NCT05972330
  org study id: V308
  nct id: NCT05972330
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the
        oral microbiome.
  This is a single arm, interventional trial on adults residing in the United States. The study
        will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at
        improving oral microbiome health according to Viome's Oral Health Score.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: None, Open Label
  measure: Viome Oral Health Score
  time frame: ~ 4 months
  description: Increase in oral health score as measured by Viome's Oral Health Score.
  arm group label: VRx MyBiotics Oral Lozenges
  arm group type: Experimental
  description: Participants will receive a 30 day supply of their personalized oral biotic lozenges.
  intervention type: Dietary Supplement
  intervention name: VRx MyBiotics Oral Lozenges
  description: VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.
  arm group label: VRx MyBiotics Oral Lozenges
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Momchilo Vuyisich
  role: Principal Investigator
  affiliation: Viome
  last name: Kaitlyn Sells
  phone: (425) 300-6933
  email: studies@viome.com
  last name: Momchilo Vuyisich
  phone: (425) 300-6933
  email: studies@viome.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor