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/NCT06015958</url>
    </required_header>
    <id_info>
      <org_study_id>BLTCT2022/9</org_study_id>
      <nct_id>NCT06015958</nct_id>
    </id_info>
    <brief_title>Probiotic Toothpaste to Assess Microbial Colonization</brief_title>
    <official_title>Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BLIS Technologies Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BLIS Technologies Limited</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 aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in&#xD;
        healthy adults&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a double blind randomized controlled study with no cross over to evaluate the&#xD;
        colonization efficacy of toothpaste containing a commercially available probiotic bacterium&#xD;
        Streptococcus salivarius M18.&#xD;
  &#xD;
        Participants will be randomly assigned to one of 2 groups for brushing teeth with a probiotic&#xD;
        toothpaste containing two different doses of Streptococcus salivarius M18 over a seven day&#xD;
        period. Saliva samples will be collected at predetermined time points pre and post&#xD;
        intervention. Colonization efficacy will be determined by enumerating the probiotic in the&#xD;
        saliva samples using standard microbiological techniques.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 29, 2023</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>
      <intervention_model_description>Participants will be randomly assigned to one of the 2 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (10 million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10)</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Microbial colonization from baseline (Day 0) to 1 hour</measure>
      <time_frame>1 hour post intervention</time_frame>
      <description>Study will determine the change in the microbial colonization efficacy of two different doses of S. salivarius M18 in a toothpaste format.&#xD;
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Microbial colonization from baseline (Day 0) to 8 hours</measure>
      <time_frame>8 hours post intervention</time_frame>
      <description>Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.&#xD;
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Microbial colonization from baseline (Day 0) to 24 hours</measure>
      <time_frame>24 hours post intervention</time_frame>
      <description>Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.&#xD;
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose</measure>
      <time_frame>8 hours after last dose following 7 days of daily brushing with probiotic toothpaste.</time_frame>
      <description>Study will determine the change in the microbial colonization efficacy of two different doses of S. salivarius M18 in a toothpaste format.&#xD;
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Microbial Colonization</condition>
    <arm_group>
      <arm_group_label>Active Comparator: Streptococcus salivarius M18 toothpaste dose 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Streptococcus salivarius M18 toothpaste containing 1 million cfu/g</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Comparator: Streptococcus salivarius M18 toothpaste dose 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Streptococcus salivarius M18 toothpaste containing 10 million cfu/g</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Streptococcus salivarius M18 toothpaste (1 million cfu)</intervention_name>
      <description>Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g&#xD;
  In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.</description>
      <arm_group_label>Active Comparator: Streptococcus salivarius M18 toothpaste dose 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Streptococcus salivarius M18 toothpaste (10 million cfu)</intervention_name>
      <description>Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g&#xD;
  In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.</description>
      <arm_group_label>Active Comparator: Streptococcus salivarius M18 toothpaste dose 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  In general good health&#xD;
  &#xD;
            -  Practise good oral hygiene&#xD;
  &#xD;
          Exclusion Criteria:-&#xD;
  &#xD;
            -  Have a history of autoimmune disease or are immunocompromised.&#xD;
  &#xD;
            -  Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week&#xD;
  &#xD;
            -  History of allergy (e.g. dairy).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Blis Technologies Ltd</name>
        <address>
          <city>Dunedin</city>
          <state>Otago</state>
          <zip>9012</zip>
          <country>New Zealand</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>New Zealand</country>
    </location_countries>
    <reference>
      <citation>Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.</citation>
      <PMID>23449874</PMID>
    </reference>
    <reference>
      <citation>Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020;18(1):161-164. doi: 10.3290/j.ohpd.a43359.</citation>
      <PMID>32099975</PMID>
    </reference>
    <reference>
      <citation>Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.</citation>
      <PMID>26491371</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>probiotic toothpaste</keyword>
    <keyword>Streptococcus salivarius M18</keyword>
    <keyword>Microbial colonization</keyword>
    <keyword>Oral Probiotic</keyword>
    <keyword>Toothpaste</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06015958
  org study id: BLTCT2022/9
  nct id: NCT06015958
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in
        healthy adults
  This is a double blind randomized controlled study with no cross over to evaluate the
        colonization efficacy of toothpaste containing a commercially available probiotic bacterium
        Streptococcus salivarius M18.
  
        Participants will be randomly assigned to one of 2 groups for brushing teeth with a probiotic
        toothpaste containing two different doses of Streptococcus salivarius M18 over a seven day
        period. Saliva samples will be collected at predetermined time points pre and post
        intervention. Colonization efficacy will be determined by enumerating the probiotic in the
        saliva samples using standard microbiological techniques.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly assigned to one of the 2 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (10 million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10)
  primary purpose: Basic Science
  masking: Single (Participant)
  masking description: A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.
  measure: Change in Microbial colonization from baseline (Day 0) to 1 hour
  time frame: 1 hour post intervention
  description: Study will determine the change in the microbial colonization efficacy of two different doses of S. salivarius M18 in a toothpaste format.
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
  measure: Change in Microbial colonization from baseline (Day 0) to 8 hours
  time frame: 8 hours post intervention
  description: Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
  measure: Change in Microbial colonization from baseline (Day 0) to 24 hours
  time frame: 24 hours post intervention
  description: Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
  measure: Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose
  time frame: 8 hours after last dose following 7 days of daily brushing with probiotic toothpaste.
  description: Study will determine the change in the microbial colonization efficacy of two different doses of S. salivarius M18 in a toothpaste format.
  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
  arm group label: Active Comparator: Streptococcus salivarius M18 toothpaste dose 1
  arm group type: Active Comparator
  description: Streptococcus salivarius M18 toothpaste containing 1 million cfu/g
  arm group label: Active Comparator: Streptococcus salivarius M18 toothpaste dose 2
  arm group type: Active Comparator
  description: Streptococcus salivarius M18 toothpaste containing 10 million cfu/g
  intervention type: Other
  intervention name: Streptococcus salivarius M18 toothpaste (1 million cfu)
  description: Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g
  In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
  arm group label: Active Comparator: Streptococcus salivarius M18 toothpaste dose 1
  intervention type: Other
  intervention name: Streptococcus salivarius M18 toothpaste (10 million cfu)
  description: Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g
  In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
  arm group label: Active Comparator: Streptococcus salivarius M18 toothpaste dose 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: New Zealand
  citation: Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
  PMID: 23449874
  citation: Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020;18(1):161-164. doi: 10.3290/j.ohpd.a43359.
  PMID: 32099975
  citation: Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.
  PMID: 26491371
  responsible party type: Sponsor
  mesh term: Communicable Diseases
  mesh term: Infections
  sharing ipd: No