<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/NCT04424888</url>
  </required_header>
  <id_info>
    <org_study_id>WB01-205</org_study_id>
    <nct_id>NCT04424888</nct_id>
  </id_info>
  <brief_title>Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study</brief_title>
  <official_title>Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pendulum Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pendulum Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the&#xD;
      potential of collecting robust, real-time clinical study measures of glucose levels using&#xD;
      Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone&#xD;
      application&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to characterize the performance of a Continuous Glucose Monitoring&#xD;
      System in medical food studies. The Freestyle Libre Glucose Sensors will be used to follow&#xD;
      subject's 8-day glucose trajectories over the course of a 5-week, double-blind,&#xD;
      placebo-controlled, 2x2 crossover, medical-food experiment. The medical food has been&#xD;
      designed to increase butyrate production and promote the health of the colonic mucin layer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Actual">June 29, 2018</completion_date>
  <primary_completion_date type="Actual">April 29, 2018</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors</measure>
    <time_frame>Through study completion, an average of 5 weeks</time_frame>
    <description>Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2-hour Interstitial Glucose Area Under the Curve (AUC)</measure>
    <time_frame>Change from baseline to 2 weeks</time_frame>
    <description>Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass</measure>
    <time_frame>Change from baseline to 2 weeks</time_frame>
    <description>Weight measured via Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration</measure>
    <time_frame>Change from baseline to 2 weeks</time_frame>
    <description>Fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples. Mass Fraction is measured and the delta between the start and end of each period is computed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors</measure>
    <time_frame>Through study completion, an average of 5 weeks</time_frame>
    <description>To measure the lifespan of CGM sensors, we recorded how many sensors were worn per participant during the study. Sensors were replaced either at the end of the recommended 10-day period, or when they were accidentally removed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Pictures Per Day</measure>
    <time_frame>2 weeks, (First intervention or second intervention)</time_frame>
    <description>Average number of pictures per day using the smartphone application per period, used to measure study fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Between CGM-sensor Scans</measure>
    <time_frame>2 weeks, (First intervention or second intervention)</time_frame>
    <description>Average number of hours between CGM-sensor scans using the smartphone application during the study period. The subjects were instructed to scan at least every eight hours because the CGM-sensor does not save the data after eight hours without scanning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM-Smartphone Usability Feedback</measure>
    <time_frame>Through study completion, an average of 5 weeks.</time_frame>
    <description>Questionnaire to assess usability of the CGM-sensor using the smartphone application.&#xD;
Question was:&#xD;
&quot;Would you recommend others to a study like this? On a scale of 1-10 with 1 being no and 10 being absolutely&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Diabetes Type 2</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>WB-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 capsules administered twice daily with morning and evening meal for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 capsules administered twice daily with morning and evening meal for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WB-011</intervention_name>
    <description>WB-011 medical food product.</description>
    <arm_group_label>WB-011</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Capsules identical to those containing WB-011.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitor</intervention_name>
    <description>Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>WB-011</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 75 years of age&#xD;
&#xD;
          -  If female, must meet all the following criteria:&#xD;
&#xD;
          -  Not pregnant or breastfeeding&#xD;
&#xD;
          -  If of childbearing potential (including peri-menopausal women who have had a menstrual&#xD;
             period within one year) must practice and be willing to continue to practice&#xD;
             appropriate birth control (defined as a method which results in a low failure rate,&#xD;
             i.e., less than 1% per year, when used consistently and correctly, such as double&#xD;
             barrier methods [male condom with spermicide, with or without cervical cap or&#xD;
             diaphragm], implants, injectable or oral contraceptives [must have been using for at&#xD;
             least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or&#xD;
             in an established relationship with a vasectomized partner) during the entire duration&#xD;
             of the study&#xD;
&#xD;
          -  Must be able to read, understand, and sign the informed consent forms (ICF) and, when&#xD;
             applicable, an authorization to use and disclose protected health information form&#xD;
             (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA]&#xD;
             legislation as modified in 2013)&#xD;
&#xD;
          -  Must be able to communicate with the investigator, and understand and comply with&#xD;
             protocol requirements&#xD;
&#xD;
          -  Must be able to wear a CG patch and perform a scan no less than once every 8 hours for&#xD;
             the duration of the sensor periods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment&#xD;
             during the study&#xD;
&#xD;
          -  Subjects using a proton pump inhibitor must be on a stable dose that will be&#xD;
             maintained throughout the study period&#xD;
&#xD;
          -  Subjects who plan to travel outside the United States during the projected study&#xD;
             period&#xD;
&#xD;
          -  Subjects who have received an experimental drug within 30 days prior to study entry&#xD;
&#xD;
          -  Subjects with known milk, peanut, or tree nut allergies&#xD;
&#xD;
          -  Subjects who have been diagnosed with a sexually transmitted disease including, but&#xD;
             not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and&#xD;
             hepatitis C&#xD;
&#xD;
          -  History of any surgery on the gastrointestinal tract except appendectomy and&#xD;
             cholecystectomy&#xD;
&#xD;
          -  Subjects with any condition that the investigator deems as a sound reason for&#xD;
             disqualification from enrollment into the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Technical Officer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pendulum Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pendulum Therapeutics Inc</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>October 10, 2022</results_first_submitted>
  <results_first_submitted_qc>November 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 8, 2022</results_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT04424888/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment through local biotechnology community network over the time period of 3/15/18-3/16/18.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>WB-011 / Placebo</title>
          <description>3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.&#xD;
Each period lasted two weeks, separated by a washout period of no-less than 3 days.&#xD;
First period - WB-011: WB-011 medical food product. Second period - Placebo: Placebo Capsules identical to those containing WB-011.</description>
        </group>
        <group group_id="P2">
          <title>Placebo / WB-011</title>
          <description>3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.&#xD;
Each period lasted two weeks, separated by a washout period of no-less than 3 days.&#xD;
First period - Placebo: Placebo Capsules identical to those containing WB-011. Second period - WB-011: WB-011 medical food product.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>WB-011 / Placebo</title>
          <description>3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.&#xD;
Each period lasted two weeks, separated by a washout period of no-less than 3 days.&#xD;
First period - WB-011: WB-011 medical food product. Second period - Placebo: Placebo Capsules identical to those containing WB-011.</description>
        </group>
        <group group_id="B2">
          <title>Placebo / WB-011</title>
          <description>3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.&#xD;
Each period lasted two weeks, separated by a washout period of no-less than 3 days.&#xD;
First period - Placebo: Placebo Capsules identical to those containing WB-011. Second period - WB-011: WB-011 medical food product.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors</title>
        <description>Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed.</description>
        <time_frame>Through study completion, an average of 5 weeks</time_frame>
        <population>Technical problems with measurement of temperature data resulting in unreliable data that were uninterpretable. Therefore the endpoint was dropped.</population>
        <group_list>
          <group group_id="O1">
            <title>WB-011</title>
            <description>3 capsules administered twice daily with morning and evening meal for 2 weeks&#xD;
WB-011: WB-011 medical food product.&#xD;
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>3 capsules administered twice daily with morning and evening meal for 2 weeks&#xD;
Placebo: Placebo Capsules identical to those containing WB-011.&#xD;
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors</title>
          <description>Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed.</description>
          <population>Technical problems with measurement of temperature data resulting in unreliable data that were uninterpretable. Therefore the endpoint was dropped.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>2-hour Interstitial Glucose Area Under the Curve (AUC)</title>
        <description>Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test.</description>
        <time_frame>Change from baseline to 2 weeks</time_frame>
        <population>Intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>WB-011</title>
            <description>Participants who received the WB-011 product during either the first or second period.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants who received the placebo product during either the first or second period.</description>
          </group>
        </group_list>
        <measure>
          <title>2-hour Interstitial Glucose Area Under the Curve (AUC)</title>
          <description>Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test.</description>
          <population>Intent to treat</population>
          <units>min * mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.2167" spread="1334.929"/>
                    <measurement group_id="O2" value="613.3667" spread="604.2183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21875</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass</title>
        <description>Weight measured via Scale</description>
        <time_frame>Change from baseline to 2 weeks</time_frame>
        <population>Intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>WB-011</title>
            <description>3 capsules administered twice daily with morning and evening meal for 2 weeks&#xD;
WB-011: WB-011 medical food product.&#xD;
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>3 capsules administered twice daily with morning and evening meal for 2 weeks&#xD;
Placebo: Placebo Capsules identical to those containing WB-011.&#xD;
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass</title>
          <description>Weight measured via Scale</description>
          <population>Intent to treat</population>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="2.131666"/>
                    <measurement group_id="O2" value="-1.72" spread="2.138224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.90625</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration</title>
        <description>Fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples. Mass Fraction is measured and the delta between the start and end of each period is computed.</description>
        <time_frame>Change from baseline to 2 weeks</time_frame>
        <population>Intent to treat; one subject did not provide stool samples.</population>
        <group_list>
          <group group_id="O1">
            <title>WB-011</title>
            <description>Participants who received the WB-011 product during either the first or second period.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants who received the placebo product during either the first or second period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration</title>
          <description>Fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples. Mass Fraction is measured and the delta between the start and end of each period is computed.</description>
          <population>Intent to treat; one subject did not provide stool samples.</population>
          <units>ng / ng</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Akkermansia muciniphila</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000143" spread="0.0000102"/>
                    <measurement group_id="O2" value="-0.00000194" spread="0.00000367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bifidobacterium infantis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000220" spread="0.0000259"/>
                    <measurement group_id="O2" value="-0.00000286" spread="0.00000639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clostridium beijerinckii</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clostridium butyricum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000000313" spread="0.00000100"/>
                    <measurement group_id="O2" value="-0.00000131" spread="0.00000294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anaerobutyricum hallii</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000371" spread="0.000585"/>
                    <measurement group_id="O2" value="-0.000118" spread="0.000230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired t-test for the species Akkermansia Munciphilae.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.020</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired t-test for the species Bifidobacterium infantis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.078</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired t-test for the species Clostridium beijerinckii.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <other_analysis_desc>No statistical test was conducted since Clostridium beijerinckii was not detected in any sample.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired t-test for the species Clostridium butyricum.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired t-test for the species Anaerobutyricum hallii.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors</title>
        <description>To measure the lifespan of CGM sensors, we recorded how many sensors were worn per participant during the study. Sensors were replaced either at the end of the recommended 10-day period, or when they were accidentally removed.</description>
        <time_frame>Through study completion, an average of 5 weeks</time_frame>
        <population>Intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>All participants accross all periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors</title>
          <description>To measure the lifespan of CGM sensors, we recorded how many sensors were worn per participant during the study. Sensors were replaced either at the end of the recommended 10-day period, or when they were accidentally removed.</description>
          <population>Intent to treat</population>
          <units>Number of sensors</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>All participants had the same number of sensors (3) throughout the study, so no statistical analysis is conducted.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Pictures Per Day</title>
        <description>Average number of pictures per day using the smartphone application per period, used to measure study fatigue.</description>
        <time_frame>2 weeks, (First intervention or second intervention)</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>First Intervention</title>
            <description>The first period that all participants go through, either product or placebo.</description>
          </group>
          <group group_id="O2">
            <title>Second Intervention</title>
            <description>The second period that all participants crossover and go through the other intervention arm, i.e. either product or placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Pictures Per Day</title>
          <description>Average number of pictures per day using the smartphone application per period, used to measure study fatigue.</description>
          <population>All participants</population>
          <units>Average number of photos per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.85" spread="2.72"/>
                    <measurement group_id="O2" value="5.46" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We test whether the average number of daily photos is greater in period 1 than in period 2.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Between CGM-sensor Scans</title>
        <description>Average number of hours between CGM-sensor scans using the smartphone application during the study period. The subjects were instructed to scan at least every eight hours because the CGM-sensor does not save the data after eight hours without scanning.</description>
        <time_frame>2 weeks, (First intervention or second intervention)</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>First Intervention</title>
            <description>The first period that all participants go through, either product or placebo.</description>
          </group>
          <group group_id="O2">
            <title>Second Intervention</title>
            <description>The second period that all participants crossover and go through the other intervention arm, i.e. either product or placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Between CGM-sensor Scans</title>
          <description>Average number of hours between CGM-sensor scans using the smartphone application during the study period. The subjects were instructed to scan at least every eight hours because the CGM-sensor does not save the data after eight hours without scanning.</description>
          <population>All participants.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.91" spread="1.99"/>
                    <measurement group_id="O2" value="4.53" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We test whether the average time between consecutive scans is smaller in period 1 than in period 2.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM-Smartphone Usability Feedback</title>
        <description>Questionnaire to assess usability of the CGM-sensor using the smartphone application.&#xD;
Question was:&#xD;
&quot;Would you recommend others to a study like this? On a scale of 1-10 with 1 being no and 10 being absolutely&quot;</description>
        <time_frame>Through study completion, an average of 5 weeks.</time_frame>
        <population>Two participants did not complete the questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Questionnaire was conducted before unblinding and focused on usability of both arms.</description>
          </group>
        </group_list>
        <measure>
          <title>CGM-Smartphone Usability Feedback</title>
          <description>Questionnaire to assess usability of the CGM-sensor using the smartphone application.&#xD;
Question was:&#xD;
&quot;Would you recommend others to a study like this? On a scale of 1-10 with 1 being no and 10 being absolutely&quot;</description>
          <population>Two participants did not complete the questionnaire.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.25" spread="1.258306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 5 weeks</time_frame>
      <desc>Used clinicaltrials.gov definitions</desc>
      <group_list>
        <group group_id="E1">
          <title>WB-011</title>
          <description>3 capsules administered twice daily with morning and evening meal for 2 weeks&#xD;
WB-011: WB-011 medical food product.&#xD;
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>3 capsules administered twice daily with morning and evening meal for 2 weeks&#xD;
Placebo: Placebo Capsules identical to those containing WB-011.&#xD;
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>James Bullard, PhD, Chief Technical Officer</name_or_title>
      <organization>Pendulum Therapeutics</organization>
      <phone>(844) 912-2256</phone>
      <email>james.bullard@pendulum.co</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04424888
org study id: WB01-205
nct id: NCT04424888
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the
      potential of collecting robust, real-time clinical study measures of glucose levels using
      Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone
      application
The goal of this study is to characterize the performance of a Continuous Glucose Monitoring
      System in medical food studies. The Freestyle Libre Glucose Sensors will be used to follow
      subject's 8-day glucose trajectories over the course of a 5-week, double-blind,
      placebo-controlled, 2x2 crossover, medical-food experiment. The medical food has been
      designed to increase butyrate production and promote the health of the colonic mucin layer.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors
time frame: Through study completion, an average of 5 weeks
description: Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed.
measure: 2-hour Interstitial Glucose Area Under the Curve (AUC)
time frame: Change from baseline to 2 weeks
description: Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test.
measure: Change in Body Mass
time frame: Change from baseline to 2 weeks
description: Weight measured via Scale
measure: Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
time frame: Change from baseline to 2 weeks
description: Fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples. Mass Fraction is measured and the delta between the start and end of each period is computed.
measure: Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors
time frame: Through study completion, an average of 5 weeks
description: To measure the lifespan of CGM sensors, we recorded how many sensors were worn per participant during the study. Sensors were replaced either at the end of the recommended 10-day period, or when they were accidentally removed.
measure: Number of Pictures Per Day
time frame: 2 weeks, (First intervention or second intervention)
description: Average number of pictures per day using the smartphone application per period, used to measure study fatigue.
measure: Time Between CGM-sensor Scans
time frame: 2 weeks, (First intervention or second intervention)
description: Average number of hours between CGM-sensor scans using the smartphone application during the study period. The subjects were instructed to scan at least every eight hours because the CGM-sensor does not save the data after eight hours without scanning.
measure: CGM-Smartphone Usability Feedback
time frame: Through study completion, an average of 5 weeks.
description: Questionnaire to assess usability of the CGM-sensor using the smartphone application.
Question was:
"Would you recommend others to a study like this? On a scale of 1-10 with 1 being no and 10 being absolutely"
arm group label: WB-011
arm group type: Experimental
description: 3 capsules administered twice daily with morning and evening meal for 2 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: 3 capsules administered twice daily with morning and evening meal for 2 weeks
intervention type: Other
intervention name: WB-011
description: WB-011 medical food product.
arm group label: WB-011
intervention type: Other
intervention name: Placebo
description: Placebo Capsules identical to those containing WB-011.
arm group label: Placebo
intervention type: Device
intervention name: Continuous Glucose Monitor
description: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
arm group label: Placebo
arm group label: WB-011
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chief Technical Officer, PhD
role: Principal Investigator
affiliation: Pendulum Therapeutics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 