<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/NCT03290482</url>
  </required_header>
  <id_info>
    <org_study_id>17-002067</org_study_id>
    <nct_id>NCT03290482</nct_id>
  </id_info>
  <brief_title>Natural History of Eosinophilic Esophagitis</brief_title>
  <acronym>EoE</acronym>
  <official_title>Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years</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>
    <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>
      Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its&#xD;
      progression and effects of treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will identify patients from their database who have been diagnosed with&#xD;
      Eosinophilic Esophagitis (EE) from the study period 2000 to 2008, based on clinical features&#xD;
      and biopsy findings. Participants will be offered a follow up evaluation that includes:&#xD;
      evaluation by the Principal Investigator, completion of questionnaires, Esophagram and&#xD;
      Esophageal sponge (EsophaCap) cytology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Natural history of treated Eosinophilic Esophagitis (EE)</measure>
    <time_frame>approximately 1 year</time_frame>
    <description>The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of untreated Eosinophilic Esophagitis (EE)</measure>
    <time_frame>approximately 1 year</time_frame>
    <description>The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of treated Eosinophilic Esophagitis (EoE)</measure>
    <time_frame>approximately 1 year</time_frame>
    <description>The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of untreated Eosinophilic Esophagitis (EoE)</measure>
    <time_frame>approximately 1 year</time_frame>
    <description>The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>EE Study Patients 2000-2008</arm_group_label>
    <description>All patients with the diagnosis of EE from the study period 2000 to 2008. Sixty patients participated in the 10 year follow up phone interview and questionnaire. These are the subjects we will contact to see if they are interested in participating in this study.&#xD;
If interested in participating, subjects will complete:&#xD;
Evaluation by the PI physical examination&#xD;
Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires&#xD;
Barium Esophagram with maximal and minimal esophageal diameter measurement&#xD;
EsophaCap cytology</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Barium Esophagram</intervention_name>
    <description>Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.</description>
    <arm_group_label>EE Study Patients 2000-2008</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EsophaCap</intervention_name>
    <description>Subjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf)</description>
    <arm_group_label>EE Study Patients 2000-2008</arm_group_label>
    <other_name>Sponge</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Physical Examination and Questionnaires</intervention_name>
    <description>Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.</description>
    <arm_group_label>EE Study Patients 2000-2008</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eosinophilic Esophagitis patients that we have been following for 10 years and participated&#xD;
        in the previous study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years of age and older&#xD;
&#xD;
          -  Previous participation in the natural history followup study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read due to: Blindness, cognitive dysfunction, or English language&#xD;
             illiteracy&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey A Alexander, 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>Cherian S, Smith NM, Forbes DA. Rapidly increasing prevalence of eosinophilic oesophagitis in Western Australia. Arch Dis Child. 2006 Dec;91(12):1000-4. doi: 10.1136/adc.2006.100974. Epub 2006 Jul 28.</citation>
    <PMID>16877474</PMID>
  </reference>
  <reference>
    <citation>Landres RT, Kuster GG, Strum WB. Eosinophilic esophagitis in a patient with vigorous achalasia. Gastroenterology. 1978 Jun;74(6):1298-1301.</citation>
    <PMID>648822</PMID>
  </reference>
  <reference>
    <citation>Fox VL, Nurko S, Furuta GT. Eosinophilic esophagitis: it's not just kid's stuff. Gastrointest Endosc. 2002 Aug;56(2):260-70. doi: 10.1016/s0016-5107(02)70188-0. No abstract available.</citation>
    <PMID>12145607</PMID>
  </reference>
  <reference>
    <citation>Straumann A, Spichtin HP, Grize L, Bucher KA, Beglinger C, Simon HU. Natural history of primary eosinophilic esophagitis: a follow-up of 30 adult patients for up to 11.5 years. Gastroenterology. 2003 Dec;125(6):1660-9. doi: 10.1053/j.gastro.2003.09.024.</citation>
    <PMID>14724818</PMID>
  </reference>
  <reference>
    <citation>Arora AS, Yamazaki K. Eosinophilic esophagitis: asthma of the esophagus? Clin Gastroenterol Hepatol. 2004 Jul;2(7):523-30. doi: 10.1016/s1542-3565(04)00236-8.</citation>
    <PMID>15224275</PMID>
  </reference>
  <reference>
    <citation>Noel RJ, Putnam PE, Rothenberg ME. Eosinophilic esophagitis. N Engl J Med. 2004 Aug 26;351(9):940-1. doi: 10.1056/NEJM200408263510924. No abstract available.</citation>
    <PMID>15329438</PMID>
  </reference>
  <reference>
    <citation>Straumann A, Simon HU. Eosinophilic esophagitis: escalating epidemiology? J Allergy Clin Immunol. 2005 Feb;115(2):418-9. doi: 10.1016/j.jaci.2004.11.006. No abstract available.</citation>
    <PMID>15696105</PMID>
  </reference>
  <reference>
    <citation>Morrow JB, Vargo JJ, Goldblum JR, Richter JE. The ringed esophagus: histological features of GERD. Am J Gastroenterol. 2001 Apr;96(4):984-9. doi: 10.1111/j.1572-0241.2001.03682.x.</citation>
    <PMID>11316216</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jeffrey A Alexander</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03290482
org study id: 17-002067
nct id: NCT03290482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its
      progression and effects of treatments.
Investigators will identify patients from their database who have been diagnosed with
      Eosinophilic Esophagitis (EE) from the study period 2000 to 2008, based on clinical features
      and biopsy findings. Participants will be offered a follow up evaluation that includes:
      evaluation by the Principal Investigator, completion of questionnaires, Esophagram and
      Esophageal sponge (EsophaCap) cytology.
observational model: Cohort
time perspective: Prospective
measure: Natural history of treated Eosinophilic Esophagitis (EE)
time frame: approximately 1 year
description: The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.
measure: Natural history of untreated Eosinophilic Esophagitis (EE)
time frame: approximately 1 year
description: The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 - item instrument in which symptoms are divided into three symptom domains.
measure: Natural history of treated Eosinophilic Esophagitis (EoE)
time frame: approximately 1 year
description: The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
measure: Natural history of untreated Eosinophilic Esophagitis (EoE)
time frame: approximately 1 year
description: The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
arm group label: EE Study Patients 2000-2008
description: All patients with the diagnosis of EE from the study period 2000 to 2008. Sixty patients participated in the 10 year follow up phone interview and questionnaire. These are the subjects we will contact to see if they are interested in participating in this study.
If interested in participating, subjects will complete:
Evaluation by the PI physical examination
Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires
Barium Esophagram with maximal and minimal esophageal diameter measurement
EsophaCap cytology
intervention type: Diagnostic Test
intervention name: Barium Esophagram
description: Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.
arm group label: EE Study Patients 2000-2008
intervention type: Device
intervention name: EsophaCap
description: Subjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf)
arm group label: EE Study Patients 2000-2008
other name: Sponge
intervention type: Diagnostic Test
intervention name: Physical Examination and Questionnaires
description: Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.
arm group label: EE Study Patients 2000-2008
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey A Alexander, 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: Cherian S, Smith NM, Forbes DA. Rapidly increasing prevalence of eosinophilic oesophagitis in Western Australia. Arch Dis Child. 2006 Dec;91(12):1000-4. doi: 10.1136/adc.2006.100974. Epub 2006 Jul 28.
PMID: 16877474
citation: Landres RT, Kuster GG, Strum WB. Eosinophilic esophagitis in a patient with vigorous achalasia. Gastroenterology. 1978 Jun;74(6):1298-1301.
PMID: 648822
citation: Fox VL, Nurko S, Furuta GT. Eosinophilic esophagitis: it's not just kid's stuff. Gastrointest Endosc. 2002 Aug;56(2):260-70. doi: 10.1016/s0016-5107(02)70188-0. No abstract available.
PMID: 12145607
citation: Straumann A, Spichtin HP, Grize L, Bucher KA, Beglinger C, Simon HU. Natural history of primary eosinophilic esophagitis: a follow-up of 30 adult patients for up to 11.5 years. Gastroenterology. 2003 Dec;125(6):1660-9. doi: 10.1053/j.gastro.2003.09.024.
PMID: 14724818
citation: Arora AS, Yamazaki K. Eosinophilic esophagitis: asthma of the esophagus? Clin Gastroenterol Hepatol. 2004 Jul;2(7):523-30. doi: 10.1016/s1542-3565(04)00236-8.
PMID: 15224275
citation: Noel RJ, Putnam PE, Rothenberg ME. Eosinophilic esophagitis. N Engl J Med. 2004 Aug 26;351(9):940-1. doi: 10.1056/NEJM200408263510924. No abstract available.
PMID: 15329438
citation: Straumann A, Simon HU. Eosinophilic esophagitis: escalating epidemiology? J Allergy Clin Immunol. 2005 Feb;115(2):418-9. doi: 10.1016/j.jaci.2004.11.006. No abstract available.
PMID: 15696105
citation: Morrow JB, Vargo JJ, Goldblum JR, Richter JE. The ringed esophagus: histological features of GERD. Am J Gastroenterol. 2001 Apr;96(4):984-9. doi: 10.1111/j.1572-0241.2001.03682.x.
PMID: 11316216
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jeffrey A Alexander
investigator title: Principal Investigator
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No