<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/NCT04473404</url>
  </required_header>
  <id_info>
    <org_study_id>DB001-2020</org_study_id>
    <nct_id>NCT04473404</nct_id>
  </id_info>
  <brief_title>Effect of a Probiotic Water on Oral Health in Adults</brief_title>
  <official_title>Evaluation of the Effect of an Oral Probiotic on Oral Bacteria and Malodor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dose Biosystems Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dose Biosystems Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of consuming a probiotic on salivary,&#xD;
      plaque, and tongue bacteria, as well as oral malodor (bad breath). Healthy volunteers will&#xD;
      consume a probiotic powder, or a placebo powder, that is dissolved in water for 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The oral cavity houses one of the most diverse microbiota in the human body. There are nearly&#xD;
      800 unique oral bacterial species identified with more species expected to be added with&#xD;
      further sampling and identification. As with microbiota of other sites in the body, a&#xD;
      balanced oral microbiota is essential to maintaining the health of the human host.&#xD;
      Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from&#xD;
      birth, and remains a predominant member of the commensal microbiota throughout life. The&#xD;
      commensal microbiota provides protection against pathogenic species associated with&#xD;
      conditions such as dental caries, periodontal disease, and oral malodor (halitosis). This&#xD;
      randomized, double-blind, placebo-controlled study is conducted to investigate the effect of&#xD;
      a Streptococcus salivarius DB-B5 strain on oral bacteria levels and halitosis. Doses of 2&#xD;
      billion and 10 billion colony forming units (CFU) per day are tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 26, 2020</completion_date>
  <primary_completion_date type="Actual">August 26, 2020</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral bacteria levels in saliva and plaque</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in the levels of the following bacteria in the saliva, and in samples of supra- and subgingival plaque: Streptococcus salivarius (total), Streptococcus salivarius DB-B5 (probiotic strain), Streptococcus mutans and Porphyromonas gingivalis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral bacteria levels on the tongue</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in the levels of the following bacteria in back-of-tongue samples: Tannerella forsythia, Prevotella (total), Streptococcus salivarius (total) and Streptococcus salivarius DB-B5 (probiotic strain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral malodor</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in OralChroma malodor readings.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Oral Bacteria</condition>
  <condition>Halitosis</condition>
  <arm_group>
    <arm_group_label>Probiotic - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Powdered probiotic with a carrier.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Powdered probiotic with a carrier.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Carrier only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Streptococcus salivarius DB-B5 - 2 billion CFU/day</intervention_name>
    <description>The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 1 billion CFU/sachet) dissolved in water twice daily for 4 weeks.</description>
    <arm_group_label>Probiotic - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Streptococcus salivarius DB-B5 - 10 billion CFU/day</intervention_name>
    <description>The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 5 billion CFU/sachet) dissolved in water twice daily for 4 weeks.</description>
    <arm_group_label>Probiotic - high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults, 18 to 65 years of age and in good general health and good oral health (no&#xD;
             active or uncontrolled diseases or conditions).&#xD;
&#xD;
          2. Presence of at least 20 natural teeth, excluding third molars.&#xD;
&#xD;
          3. Read and sign the Research Subject Information and Consent Form.&#xD;
&#xD;
          4. Have an OralChroma reading ≥ 125 ppb hydrogen sulfide (H2S) gas, volatile sulfur&#xD;
             compound (VSC) (at least 8-12 hours after eating or drinking or oral hygiene) at&#xD;
             Baseline.&#xD;
&#xD;
          5. Willingness to use the assigned products according to instructions, attend scheduled&#xD;
             appointments, and likelihood of completing the study.&#xD;
&#xD;
          6. Males and females with reproductive potential agree to use medically acceptable&#xD;
             contraception, as determined by the investigator, for the duration of the study and 30&#xD;
             days after study completion and attest to having used it for three months prior to&#xD;
             screening.&#xD;
&#xD;
          7. Females of child-bearing potential agree to submit to a urine pregnancy test at&#xD;
             screening and at the end of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fewer than 20 natural, uncrowned teeth.&#xD;
&#xD;
          2. Active or chronic dental disease.&#xD;
&#xD;
          3. Self-reported dry mouth (xerostomia) by questionnaire.&#xD;
&#xD;
          4. Have had or used any of the following in the past three months: antibiotic treatment,&#xD;
             a dental cleaning, mouthrinse.&#xD;
&#xD;
          5. Regular use of probiotic supplements or regular consumption of probiotic rich foods&#xD;
             such as yoghurt or kefir in the past month.&#xD;
&#xD;
          6. Require antibiotic prophylaxis for dental or any treatment.&#xD;
&#xD;
          7. Removable or fixed dental appliances (no implants; crowns allowed if subject has at&#xD;
             least 20 uncrowned teeth)&#xD;
&#xD;
          8. Pregnant or planning to become pregnant during the study period, or breastfeeding.&#xD;
&#xD;
          9. Uses tobacco products (including smokeless, vaping, and nicotine chewing&#xD;
             gums/sprays/lozenges).&#xD;
&#xD;
         10. Chronic or acute illness such as heart disease, diabetes, cancer, autoimmune condition&#xD;
             or HIV that could impact outcome of the study in the opinion of the investigator.&#xD;
&#xD;
         11. Use of a dental product or is on a medication/treatment that could impact outcome of&#xD;
             the study in the opinion of the investigator.&#xD;
&#xD;
         12. Is unwilling or unable to provide informed consent and follow study procedures.&#xD;
&#xD;
         13. Has participated in any clinical study within 30 days.&#xD;
&#xD;
         14. Clinical site personnel or relative or partner of clinical site personnel.&#xD;
&#xD;
         15. Any other condition or situation that may increase the risk associated with study&#xD;
             participation or may interfere with the study results in the opinion of the&#xD;
             investigator.&#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>Jeffery L. Milleman, DDS, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salus Research, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salus Research, Inc.</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotic</keyword>
  <keyword>Oral microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Halitosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04473404
org study id: DB001-2020
nct id: NCT04473404
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effects of consuming a probiotic on salivary,
      plaque, and tongue bacteria, as well as oral malodor (bad breath). Healthy volunteers will
      consume a probiotic powder, or a placebo powder, that is dissolved in water for 4 weeks.
The oral cavity houses one of the most diverse microbiota in the human body. There are nearly
      800 unique oral bacterial species identified with more species expected to be added with
      further sampling and identification. As with microbiota of other sites in the body, a
      balanced oral microbiota is essential to maintaining the health of the human host.
      Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from
      birth, and remains a predominant member of the commensal microbiota throughout life. The
      commensal microbiota provides protection against pathogenic species associated with
      conditions such as dental caries, periodontal disease, and oral malodor (halitosis). This
      randomized, double-blind, placebo-controlled study is conducted to investigate the effect of
      a Streptococcus salivarius DB-B5 strain on oral bacteria levels and halitosis. Doses of 2
      billion and 10 billion colony forming units (CFU) per day are tested.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Oral bacteria levels in saliva and plaque
time frame: 4 weeks
description: Change in the levels of the following bacteria in the saliva, and in samples of supra- and subgingival plaque: Streptococcus salivarius (total), Streptococcus salivarius DB-B5 (probiotic strain), Streptococcus mutans and Porphyromonas gingivalis.
measure: Oral bacteria levels on the tongue
time frame: 4 weeks
description: Change in the levels of the following bacteria in back-of-tongue samples: Tannerella forsythia, Prevotella (total), Streptococcus salivarius (total) and Streptococcus salivarius DB-B5 (probiotic strain).
measure: Oral malodor
time frame: 4 weeks
description: Change in OralChroma malodor readings.
arm group label: Probiotic - low dose
arm group type: Experimental
description: Powdered probiotic with a carrier.
arm group label: Probiotic - high dose
arm group type: Experimental
description: Powdered probiotic with a carrier.
arm group label: Placebo
arm group type: Placebo Comparator
description: Carrier only.
intervention type: Dietary Supplement
intervention name: Streptococcus salivarius DB-B5 - 2 billion CFU/day
description: The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 1 billion CFU/sachet) dissolved in water twice daily for 4 weeks.
arm group label: Probiotic - low dose
intervention type: Dietary Supplement
intervention name: Streptococcus salivarius DB-B5 - 10 billion CFU/day
description: The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 5 billion CFU/sachet) dissolved in water twice daily for 4 weeks.
arm group label: Probiotic - high dose
intervention type: Other
intervention name: Placebo
description: The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffery L. Milleman, DDS, MPA
role: Principal Investigator
affiliation: Salus Research, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Halitosis