<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/NCT01700712</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2010-112</org_study_id>
    <nct_id>NCT01700712</nct_id>
  </id_info>
  <brief_title>Acid Production in Dental Plaque After Exposure to Probiotic Bacteria</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioGaia AB</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Calcin foundation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <brief_summary>
    <textblock>
      The increasing interest in probiotic lactobacilli in health maintenance has raised the&#xD;
      question of potential risks. One possible side effect could be an increased acidogenicity in&#xD;
      dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli&#xD;
      on plaque lactic acid (LA) production in vitro and in vivo.&#xD;
&#xD;
      Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM&#xD;
      17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over&#xD;
      trial. The concentration of LA in supragingival plaque samples was determined at baseline and&#xD;
      after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated&#xD;
      with chair-side methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acid production in plaque after exposure to probiotic bacteria</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acid producton in plaque after in vitro exposure to probiotic bacteria</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 tablets a day for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 tablets a day for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic Lactobacilli reuteri</intervention_name>
    <arm_group_label>L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate to high counts of salivary mutans streptococci (&gt;104 CFU) as estimated with&#xD;
             the Dentocult SM chair-side test,&#xD;
&#xD;
          -  no visible open caries lesions or periodontal disease,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers,&#xD;
&#xD;
          -  ingestion of probiotic bacteria within the last two months,&#xD;
&#xD;
          -  ingestion of antibiotics within the last two months&#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>Mette K Keller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Mette Kirstine Keller</investigator_full_name>
    <investigator_title>Reasearch Associate</investigator_title>
  </responsible_party>
  <keyword>Caries, probiotic bacteria</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01700712
org study id: H-2-2010-112
nct id: NCT01700712
lead sponsor: 
collaborator: 
collaborator: 
The increasing interest in probiotic lactobacilli in health maintenance has raised the
      question of potential risks. One possible side effect could be an increased acidogenicity in
      dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli
      on plaque lactic acid (LA) production in vitro and in vivo.

      Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM
      17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over
      trial. The concentration of LA in supragingival plaque samples was determined at baseline and
      after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated
      with chair-side methods.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Acid production in plaque after exposure to probiotic bacteria
time frame: 2 weeks
measure: Acid producton in plaque after in vitro exposure to probiotic bacteria
time frame: 1 hour
arm group label: L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
arm group type: Active Comparator
description: 2 tablets a day for 2 weeks
arm group label: Sugar pill
arm group type: Placebo Comparator
description: 2 tablets a day for 2 weeks
intervention type: Dietary Supplement
intervention name: Probiotic Lactobacilli reuteri
arm group label: L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Sugar pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mette K Keller, PhD
role: Principal Investigator
affiliation: University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Mette Kirstine Keller
investigator title: Reasearch Associate