<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/NCT04457661</url>
  </required_header>
  <id_info>
    <org_study_id>20-036-A</org_study_id>
    <nct_id>NCT04457661</nct_id>
  </id_info>
  <brief_title>Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals</brief_title>
  <acronym>TCI711</acronym>
  <official_title>Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TCI Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TCI Co., Ltd.</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>
      Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of&#xD;
      alcohol removal in adult individuals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>5 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>15 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>30 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>60 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>90 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>120 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>150 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath Alcohol Level</measure>
    <time_frame>180 minutes after drinking a certain volume of whisky</time_frame>
    <description>A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Breath Alcohol Level</condition>
  <arm_group>
    <arm_group_label>TCI711 probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Taking one capsule (containing 10^10 of Bacillus coagulans TCI711) daily for one month</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bacillus coagulans TCI711</intervention_name>
    <description>Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.</description>
    <arm_group_label>TCI711 probiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers aged between 20 to 60.&#xD;
&#xD;
          -  Systolic pressure below 140&#xD;
&#xD;
          -  Score of C-CAGE Questionnaire below 8 (male)/6 (female)&#xD;
&#xD;
          -  Prohibiting other supplements before 2 weeks of the study and during the study&#xD;
&#xD;
          -  Prohibiting alcohol drinks before 24 hours of the study&#xD;
&#xD;
          -  Prohibiting caffeine drinks before 12 hours of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol or drug allergy&#xD;
&#xD;
          -  Liver, kidney, cardiovascular, or chronic diseases&#xD;
&#xD;
          -  Other severe disorders&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Already involved in clinical testing&#xD;
&#xD;
          -  Other supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>GeNext</name>
      <address>
        <city>Taipei City</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04457661
org study id: 20-036-A
nct id: NCT04457661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of
      alcohol removal in adult individuals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Breath Alcohol Level
time frame: 5 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 15 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 30 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 60 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 90 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 120 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 150 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
measure: Breath Alcohol Level
time frame: 180 minutes after drinking a certain volume of whisky
description: A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
arm group label: TCI711 probiotic
arm group type: Experimental
description: Taking one capsule (containing 10^10 of Bacillus coagulans TCI711) daily for one month
intervention type: Dietary Supplement
intervention name: Bacillus coagulans TCI711
description: Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.
arm group label: TCI711 probiotic
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No