xml: <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/NCT06004596</url>
    </required_header>
    <id_info>
      <org_study_id>CDX-CD-PRO-442</org_study_id>
      <nct_id>NCT06004596</nct_id>
    </id_info>
    <brief_title>Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)</brief_title>
    <official_title>Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairn Diagnostics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical College of Wisconsin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cairn Diagnostics</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_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric&#xD;
        Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose&#xD;
        children that are suspected of having a condition called gastroparesis, which means that food&#xD;
        doesn't empty from their stomach normally.&#xD;
  &#xD;
        Participants will blow into test tubes to collect breath samples before and after eating a&#xD;
        scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a&#xD;
        blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a&#xD;
        non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in&#xD;
        breath before and after eating the GEBT meal can measure how fast food is emptying from the&#xD;
        stomach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Children will complete questionnaires to ensure that they are qualified to enter the study&#xD;
        and are likely to have normal gastric emptying rates. Informed consent/assent will be&#xD;
        obtained.&#xD;
  &#xD;
        Breath samples will be collected by children blowing into test tubes before and after eating&#xD;
        a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered&#xD;
        via telehealth or at one of the children's hospital clinics.&#xD;
  &#xD;
        Researchers will analyze results from different age groups to see if there are differences in&#xD;
        normal gastric emptying in younger/older children and boys/girls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 17, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)</measure>
      <time_frame>15 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 15 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 30 minutes (min-1)</measure>
      <time_frame>30 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 30 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 45 minutes (min-1)</measure>
      <time_frame>45 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 45 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 60 minutes (min-1)</measure>
      <time_frame>60 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 60 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 90 minutes (min-1)</measure>
      <time_frame>90 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 90 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 120 minutes (min-1)</measure>
      <time_frame>120 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 120 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 150 minutes (min-1)</measure>
      <time_frame>150 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 150 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 180 minutes (min-1)</measure>
      <time_frame>180 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 180 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 210 minutes</measure>
      <time_frame>210 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 210 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>kPCD at 240 minutes (min-1)</measure>
      <time_frame>240 minutes</time_frame>
      <description>13CO2 excretion rate calculated at 240 minutes after meal completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Test meal/test completion</measure>
      <time_frame>up to 20 minutes</time_frame>
      <description>Participant was able to successfully consume the meal/complete the test - Measured by determining whether box on test request form checked or not checked and whether or not all breath samples were collected/able to be analyzed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tmax (mins)</measure>
      <time_frame>90 to 240 minutes</time_frame>
      <description>Time of maximum excretion rate - time at which the largest kPCD is observed</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Gastroparesis</condition>
    <arm_group>
      <arm_group_label>Reference Range determination</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biological Variability</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>13C-Spirulina Gastric Emptying Breath Test (GEBT)</intervention_name>
      <description>Diagnostic test</description>
      <arm_group_label>Reference Range determination</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat</intervention_name>
      <description>Diagnostic test - repeat for biological variability deterination</description>
      <arm_group_label>Biological Variability</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children ages 7 to 18 years who provide written assent and whose parents provide&#xD;
               written consent for participation&#xD;
  &#xD;
            -  Healthy and without any significant prior medical history or developmental delays&#xD;
  &#xD;
            -  Able to eat the test meal and provide breath samples.-&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that&#xD;
          may cause malabsorption, neurological) or psychiatric disease&#xD;
  &#xD;
            -  Chronic pulmonary disease including moderate/severe reactive airway disease requiring&#xD;
               treatment with a daily inhaler&#xD;
  &#xD;
            -  Type 1 or 2 Diabetes&#xD;
  &#xD;
            -  Chronic gastrointestinal symptoms or functional gastrointestinal disorders&#xD;
  &#xD;
            -  Mental retardation or pervasive developmental disorder&#xD;
  &#xD;
            -  Currently receiving prescription drug therapy that may affect gastric motor function&#xD;
               or sensation&#xD;
  &#xD;
            -  Any over-the-counter or herbal supplements that may affect gastric motor function or&#xD;
               sensation&#xD;
  &#xD;
            -  Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free&#xD;
               crackers with the test meal) or known intolerance to any ingredient in the test meal&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Catherine E Williams, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairn Diagnostics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Catherine E Williams, PhD</last_name>
      <phone>6153765464</phone>
      <phone_ext>103</phone_ext>
      <email>cwilliams@cairndx.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ethan McClain, PhD</last_name>
      <phone>6153765464</phone>
      <phone_ext>105</phone_ext>
      <email>emcclain@cairndx.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cairn Diagnostics</name>
        <address>
          <city>Brentwood</city>
          <state>Tennessee</state>
          <zip>37027</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Texas Children's Hospital/Baylor College of Medicine</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Heather Charron</last_name>
        <phone>713-798-0381</phone>
        <email>heather.charron@bcm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Bruno Chumpitazi, MD</last_name>
        <phone>8328223616</phone>
        <email>chumpita@bcm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Bruno Chumpitazi, MD MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert J Shulman, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical College of Wisconsin</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Monica Grimm</last_name>
        <phone>414-266-6111</phone>
        <email>mgrimm@mcw.edu</email>
      </contact>
      <contact_backup>
        <last_name>katja kovacic, MD</last_name>
        <phone>4162663690</phone>
        <email>kkovacic@mcw.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Katja Kovacic, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>Gastroparesis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004596
  org study id: CDX-CD-PRO-442
  nct id: NCT06004596
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric
        Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose
        children that are suspected of having a condition called gastroparesis, which means that food
        doesn't empty from their stomach normally.
  
        Participants will blow into test tubes to collect breath samples before and after eating a
        scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a
        blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a
        non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in
        breath before and after eating the GEBT meal can measure how fast food is emptying from the
        stomach.
  Children will complete questionnaires to ensure that they are qualified to enter the study
        and are likely to have normal gastric emptying rates. Informed consent/assent will be
        obtained.
  
        Breath samples will be collected by children blowing into test tubes before and after eating
        a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered
        via telehealth or at one of the children's hospital clinics.
  
        Researchers will analyze results from different age groups to see if there are differences in
        normal gastric emptying in younger/older children and boys/girls.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)
  time frame: 15 minutes
  description: 13CO2 excretion rate calculated at 15 minutes after meal completion
  measure: kPCD at 30 minutes (min-1)
  time frame: 30 minutes
  description: 13CO2 excretion rate calculated at 30 minutes after meal completion
  measure: kPCD at 45 minutes (min-1)
  time frame: 45 minutes
  description: 13CO2 excretion rate calculated at 45 minutes after meal completion
  measure: kPCD at 60 minutes (min-1)
  time frame: 60 minutes
  description: 13CO2 excretion rate calculated at 60 minutes after meal completion
  measure: kPCD at 90 minutes (min-1)
  time frame: 90 minutes
  description: 13CO2 excretion rate calculated at 90 minutes after meal completion
  measure: kPCD at 120 minutes (min-1)
  time frame: 120 minutes
  description: 13CO2 excretion rate calculated at 120 minutes after meal completion
  measure: kPCD at 150 minutes (min-1)
  time frame: 150 minutes
  description: 13CO2 excretion rate calculated at 150 minutes after meal completion
  measure: kPCD at 180 minutes (min-1)
  time frame: 180 minutes
  description: 13CO2 excretion rate calculated at 180 minutes after meal completion
  measure: kPCD at 210 minutes
  time frame: 210 minutes
  description: 13CO2 excretion rate calculated at 210 minutes after meal completion
  measure: kPCD at 240 minutes (min-1)
  time frame: 240 minutes
  description: 13CO2 excretion rate calculated at 240 minutes after meal completion
  measure: Test meal/test completion
  time frame: up to 20 minutes
  description: Participant was able to successfully consume the meal/complete the test - Measured by determining whether box on test request form checked or not checked and whether or not all breath samples were collected/able to be analyzed
  measure: Tmax (mins)
  time frame: 90 to 240 minutes
  description: Time of maximum excretion rate - time at which the largest kPCD is observed
  arm group label: Reference Range determination
  arm group type: Other
  description: 13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants
  arm group label: Biological Variability
  arm group type: Active Comparator
  description: 13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.
  intervention type: Diagnostic Test
  intervention name: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
  description: Diagnostic test
  arm group label: Reference Range determination
  intervention type: Diagnostic Test
  intervention name: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
  description: Diagnostic test - repeat for biological variability deterination
  arm group label: Biological Variability
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Catherine E Williams, PhD
  role: Principal Investigator
  affiliation: Cairn Diagnostics
  last name: Catherine E Williams, PhD
  phone: 6153765464
  phone ext: 103
  email: cwilliams@cairndx.com
  last name: Ethan McClain, PhD
  phone: 6153765464
  phone ext: 105
  email: emcclain@cairndx.com
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Gastroparesis
  sharing ipd: No