<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/NCT03812575</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-18-1019 (pilot)</org_study_id>
    <nct_id>NCT03812575</nct_id>
  </id_info>
  <brief_title>The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Pilot)</brief_title>
  <official_title>The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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 the study is to evaluate of the relationships between fractionated exhaled&#xD;
      nitric oxide, disease activity, and symptom severity in patients with eosinophilic&#xD;
      esophagitis compared to those without eosinophilic esophagitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fractionated exhaled nitric oxide (FeNO) level</measure>
    <time_frame>baseline (day of first endoscopy)</time_frame>
    <description>The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fractionated exhaled nitric oxide (FeNO) level</measure>
    <time_frame>at about 4-12 weeks (day of second endoscopy)</time_frame>
    <description>The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Esophageal eosinophil counts as assessed by biopsy</measure>
    <time_frame>baseline (day of first endoscopy)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Esophageal eosinophil counts as assessed by biopsy</measure>
    <time_frame>at about 4-12 weeks (day of second endoscopy)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum eosinophil counts as assessed by complete blood count (CBC)</measure>
    <time_frame>baseline (day of first endoscopy)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire</measure>
    <time_frame>baseline (day of first endoscopy)</time_frame>
    <description>The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire</measure>
    <time_frame>at about 4-12 weeks (day of second endoscopy)</time_frame>
    <description>The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>Active eosinophilic esophagitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Eosinophilic esophagitis in remission</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>No eosinophilic esophagitis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients will be recruited from the outpatient clinic of the Pediatric Gastroenterology&#xD;
        Division of The University of Texas Health and Science Center at Houston.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patient who will undergo esophagogastroduodenoscopy with biopsies at&#xD;
             Children's Memorial Hermann Hospital, as part of the standard of care in the&#xD;
             evaluation of EoE&#xD;
&#xD;
          -  Able to perform the single-breath exhalation for the hand-held analyzer, NIOX MINO&#xD;
             (Aerocrine, Sweden)&#xD;
&#xD;
          -  Signed informed consent by a parent or legal guardian&#xD;
&#xD;
          -  Signed assent form by the child/adolescent subjects 7-18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past medical history of asthma, allergic rhinitis, IBD, parasitic infection, hay fever&#xD;
             and any exposure to smoking (including secondhand smoke) because these disorders are&#xD;
             known to affect the FeNO levels&#xD;
&#xD;
          -  Active respiratory tract infections at the time of FeNO evaluation because this can&#xD;
             affect the result of the FeNO as well&#xD;
&#xD;
          -  Asthma questionnaire and/or Spirometry test consistent with asthma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tu T Mai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Tu Thanh Mai</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</mesh_term>
  </condition_browse>
  <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/NCT03812575
org study id: HSC-MS-18-1019 (pilot)
nct id: NCT03812575
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate of the relationships between fractionated exhaled
      nitric oxide, disease activity, and symptom severity in patients with eosinophilic
      esophagitis compared to those without eosinophilic esophagitis.
observational model: Cohort
time perspective: Prospective
measure: Fractionated exhaled nitric oxide (FeNO) level
time frame: baseline (day of first endoscopy)
description: The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
measure: Fractionated exhaled nitric oxide (FeNO) level
time frame: at about 4-12 weeks (day of second endoscopy)
description: The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
measure: Esophageal eosinophil counts as assessed by biopsy
time frame: baseline (day of first endoscopy)
measure: Esophageal eosinophil counts as assessed by biopsy
time frame: at about 4-12 weeks (day of second endoscopy)
measure: Serum eosinophil counts as assessed by complete blood count (CBC)
time frame: baseline (day of first endoscopy)
measure: Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire
time frame: baseline (day of first endoscopy)
description: The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.
measure: Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire
time frame: at about 4-12 weeks (day of second endoscopy)
description: The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.
arm group label: Active eosinophilic esophagitis
arm group label: Eosinophilic esophagitis in remission
arm group label: No eosinophilic esophagitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Tu T Mai, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Tu Thanh Mai
investigator title: Assistant Professor
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No