<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/NCT02227836</url>
  </required_header>
  <id_info>
    <org_study_id>14-002050</org_study_id>
    <secondary_id>UL1TR000135</secondary_id>
    <nct_id>NCT02227836</nct_id>
  </id_info>
  <brief_title>Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis</brief_title>
  <acronym>EoE</acronym>
  <official_title>Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to see if allergy patch testing (APT) can help predict effective&#xD;
      dietary therapy in patients with eosinophilic esophagitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are&#xD;
      nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then&#xD;
      meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30)&#xD;
      following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a&#xD;
      standard clinically indicated Six Food Elimination Diet treatment completed. Patients will&#xD;
      follow up with one of three investigators following the elimination diet who will be blinded&#xD;
      to the results of the APT. During this visit responders and nonresponders will be identified&#xD;
      and nonresponders will complete a directed elimination diet based on APT results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of Patch Testing</measure>
    <time_frame>up to 120 hours after application of patch test</time_frame>
    <description>Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>Allergy Patch Testing APT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will undergo APT testing per the following protocol:&#xD;
2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.&#xD;
Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits&#xD;
The patches will be removed at 48 hours, and results read at 72 and 120 hours after application&#xD;
Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Allergy Patch Testing</intervention_name>
    <arm_group_label>Allergy Patch Testing APT</arm_group_label>
    <other_name>APT</other_name>
    <other_name>Patch testing</other_name>
    <other_name>Allergy testing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults ages 18-90&#xD;
&#xD;
          -  Patients with EoE, defined as dysphagia with histologic finding of greater than or&#xD;
             equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal&#xD;
             biopsy&#xD;
&#xD;
          -  Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal&#xD;
             biopsy after at least 8 weeks of twice daily PPI therapy&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with conditions known to be associated with esophageal eosinophilia,&#xD;
             including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome&#xD;
&#xD;
          -  Topical swallowed steroids within 8 weeks of study enrollment&#xD;
&#xD;
          -  Dermatologic conditions precluding application of Finn chambers to the skin for APT&#xD;
&#xD;
          -  Inability to read due to: Blindness, cognitive dysfunction, or English language&#xD;
             illiteracy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karthik Ravi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <reference>
    <citation>Eckmann JD, Ravi K, Katzka DA, Davis DR, See JA, Geno DR, Kryzer LA, Alexander JA. Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study. Dig Dis Sci. 2018 Mar;63(3):694-702. doi: 10.1007/s10620-018-4928-4. Epub 2018 Jan 18.</citation>
    <PMID>29349695</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>March 1, 2019</results_first_submitted>
  <results_first_submitted_qc>March 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2019</results_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Karthik Ravi, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Allergy Patch testing</keyword>
  <keyword>Eosinophilic Esophagitis</keyword>
  <keyword>EoE</keyword>
  <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>
  <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>October 30, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT02227836/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Allergy Patch Testing APT</title>
          <description>Patient will undergo Atopy Patch Testing (APT) per the following protocol:&#xD;
2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.&#xD;
Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits&#xD;
The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.&#xD;
Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Allergy Patch Testing APT</title>
          <description>Patient will undergo APT testing per the following protocol:&#xD;
2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.&#xD;
Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits&#xD;
The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.&#xD;
Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43" spread="11"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Allergic history</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sensitivity of Patch Testing</title>
        <description>Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings</description>
        <time_frame>up to 120 hours after application of patch test</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Allergy Patch Testing APT</title>
            <description>Patient will undergo APT testing per the following protocol:&#xD;
2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.&#xD;
Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits&#xD;
The patches will be removed at 48 hours, and results read at 72 hours after application.&#xD;
Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of Patch Testing</title>
          <description>Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data were collected from baseline until 2 weeks after completion of the final study visit for each subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Allergy Patch Testing APT</title>
          <description>Patient will undergo APT testing per the following protocol:&#xD;
2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.&#xD;
Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits&#xD;
The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.&#xD;
Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).</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="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
              </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>Karthik Ravi, MD</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-4824</phone>
      <email>Ravi.Karthik@mayo.edu</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/NCT02227836
org study id: 14-002050
secondary id: UL1TR000135
nct id: NCT02227836
lead sponsor: 
has dmc: No
This study is being done to see if allergy patch testing (APT) can help predict effective
      dietary therapy in patients with eosinophilic esophagitis.
Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are
      nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then
      meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30)
      following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a
      standard clinically indicated Six Food Elimination Diet treatment completed. Patients will
      follow up with one of three investigators following the elimination diet who will be blinded
      to the results of the APT. During this visit responders and nonresponders will be identified
      and nonresponders will complete a directed elimination diet based on APT results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of Patch Testing
time frame: up to 120 hours after application of patch test
description: Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
arm group label: Allergy Patch Testing APT
arm group type: Experimental
description: Patient will undergo APT testing per the following protocol:
2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.
Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits
The patches will be removed at 48 hours, and results read at 72 and 120 hours after application
Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).
intervention type: Device
intervention name: Allergy Patch Testing
arm group label: Allergy Patch Testing APT
other name: APT
other name: Patch testing
other name: Allergy testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Karthik Ravi, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
citation: Eckmann JD, Ravi K, Katzka DA, Davis DR, See JA, Geno DR, Kryzer LA, Alexander JA. Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study. Dig Dis Sci. 2018 Mar;63(3):694-702. doi: 10.1007/s10620-018-4928-4. Epub 2018 Jan 18.
PMID: 29349695
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Karthik Ravi, M.D.
investigator title: Principal Investigator
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 