<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/NCT04492631</url>
  </required_header>
  <id_info>
    <org_study_id>P1940120</org_study_id>
    <nct_id>NCT04492631</nct_id>
  </id_info>
  <brief_title>Safety of an Oral Probiotic in Healthy Adults</brief_title>
  <official_title>A 4-Week Study to Evaluate the Safety of a Probiotic Water Containing Streptococcus Salivarius DB-B5 in Healthy Volunteer Subjects</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 safety of an oral probiotic in healthy&#xD;
      individuals.&#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 human 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. This&#xD;
      randomized, double-blind, placebo-controlled study is conducted to investigate the safety and&#xD;
      tolerability of a Streptococcus salivarius DB-B5 strain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">September 21, 2020</completion_date>
  <primary_completion_date type="Actual">September 21, 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>Reports of adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>Reports of adverse events will be collected and compared between the probiotic and placebo groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Gastrointestinal tolerability to the test products will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is composed of 15 items covering 5 dimensions: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of abnormal blood laboratory test results</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in hematology parameters (complete blood count including differentials and platelets).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of abnormal clinical chemistry parameters test results</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in clinical chemistry parameters (basic metabolic panel, hepatic function panel).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of abnormal urinalysis test results</measure>
    <time_frame>4 weeks</time_frame>
    <description>Urine samples will be collected at baseline and end-of-study visits to assess for changes in standard urinalysis parameters (specific gravity, pH, ketones, glucose, blood, bilirubin, and leukocyte esterase).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy Adults</condition>
  <arm_group>
    <arm_group_label>Probiotic</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</intervention_name>
    <description>Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are 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. Have a body mass index (BMI) range of 18.5 - 35 kg/m^2;&#xD;
&#xD;
          3. Have no known food allergies or intolerances;&#xD;
&#xD;
          4. Have normal or acceptable to the Investigator vital signs (blood pressure, heart rate,&#xD;
             respiratory rate, temperature) at screening and Day -1 and normal laboratory values&#xD;
             and physical exam findings at screening;&#xD;
&#xD;
          5. Agree not to make any major changes to their diet during the study;&#xD;
&#xD;
          6. Read and sign the Research Subject Information and Consent Form;&#xD;
&#xD;
          7. Are willing to use the assigned products according to instructions, attend scheduled&#xD;
             appointments, and complete the study;&#xD;
&#xD;
          8. Are males and females who agree to use medically acceptable contraception&#xD;
             (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with&#xD;
             spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal&#xD;
             ligation; abstinence or vasectomies are acceptable if the female subject agrees to&#xD;
             implement two of the other acceptable methods of birth control if her&#xD;
             lifestyle/partner changes) for the duration of the study and 30 days after study&#xD;
             completion and attest to having used it for three months prior to screening, if of&#xD;
             child-bearing potential;&#xD;
&#xD;
          9. If subject is a female of child-bearing potential, agrees to submit to a urine&#xD;
             pregnancy test (UPT) at screening, Day -1 and at the end of study / early termination&#xD;
             visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have self-reported history of active or chronic dental or medical disease;&#xD;
&#xD;
          2. Are prone to gas, bloating, or diarrhea;&#xD;
&#xD;
          3. Have received antibiotic treatment in the three months prior to Day 1 or are unwilling&#xD;
             to refrain from antibiotic use during the study;&#xD;
&#xD;
          4. Used probiotic supplements or consumed probiotic rich foods such as yogurt or kefir&#xD;
             within 30 days prior to Day 1 or are unwilling to refrain from the use of probiotic&#xD;
             supplements or probiotic rich foods for the duration of the study, even if they are&#xD;
             for non-oral health reasons (e.g., vaginal or gut health probiotics);&#xD;
&#xD;
          5. Are pregnant, planning to become pregnant during the study period, or are&#xD;
             breastfeeding a child;&#xD;
&#xD;
          6. Self-reported current users of tobacco products, vaping products, cannabis, and/or&#xD;
             nicotine replacement therapy (gums, lozenges, sprays, etc.);&#xD;
&#xD;
          7. Frequent users of alcohol, defined as consumption of 21 units or more of alcoholic&#xD;
             beverage per week (21 units = 6 L of beer, 2.5 L of wine, or 500 mL of spirits);&#xD;
&#xD;
          8. Used over-the-counter (OTC) laxatives or any other medications, supplements, or&#xD;
             products that, in the opinion of the Investigator, could influence the endpoints in&#xD;
             this study within 30 days prior to Day 1 or are unwilling to refrain from the use of&#xD;
             these products for the duration of the study;&#xD;
&#xD;
          9. Have chronic or acute illness such as heart disease, diabetes, cancer, autoimmune&#xD;
             conditions, or history of human immunodeficiency virus (HIV) that, in the opinion of&#xD;
             the Investigator, could impact the outcome of the study;&#xD;
&#xD;
         10. Have 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;
&#xD;
         11. Are unwilling or unable to provide informed consent and follow study procedures;&#xD;
&#xD;
         12. Have participated in any clinical study within the 30 days prior to Day 1;&#xD;
&#xD;
         13. Are clinical site personnel or relative or partner of clinical site personnel.&#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>Michael Casser, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>TKL Research, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TKL Research, Inc.</name>
      <address>
        <city>Fair Lawn</city>
        <state>New Jersey</state>
        <zip>07410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>October 16, 2020</last_update_submitted>
  <last_update_submitted_qc>October 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04492631
org study id: P1940120
nct id: NCT04492631
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety of an oral probiotic in healthy
      individuals.
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 human 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. This
      randomized, double-blind, placebo-controlled study is conducted to investigate the safety and
      tolerability of a Streptococcus salivarius DB-B5 strain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Reports of adverse events
time frame: 4 weeks
description: Reports of adverse events will be collected and compared between the probiotic and placebo groups.
measure: Change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)
time frame: 4 weeks
description: Gastrointestinal tolerability to the test products will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is composed of 15 items covering 5 dimensions: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
measure: Occurrence of abnormal blood laboratory test results
time frame: 4 weeks
description: Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in hematology parameters (complete blood count including differentials and platelets).
measure: Occurrence of abnormal clinical chemistry parameters test results
time frame: 4 weeks
description: Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in clinical chemistry parameters (basic metabolic panel, hepatic function panel).
measure: Occurrence of abnormal urinalysis test results
time frame: 4 weeks
description: Urine samples will be collected at baseline and end-of-study visits to assess for changes in standard urinalysis parameters (specific gravity, pH, ketones, glucose, blood, bilirubin, and leukocyte esterase).
arm group label: Probiotic
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
description: Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.
arm group label: Probiotic
intervention type: Other
intervention name: Placebo
description: Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once 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: Michael Casser, M.D.
role: Principal Investigator
affiliation: TKL Research, Inc.
facility: 
country: United States
responsible party type: Sponsor