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Natural History of Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT03290482
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic

Brief Summary:
Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Diagnostic Test: Barium Esophagram Device: EsophaCap Diagnostic Test: Physical Examination and Questionnaires

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EE Study Patients 2000-2008

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:

  1. Evaluation by the PI physical examination
  2. Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires
  3. Barium Esophagram with maximal and minimal esophageal diameter measurement
  4. EsophaCap cytology
Diagnostic Test: Barium Esophagram
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.

Device: EsophaCap
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)
Other Name: Sponge

Diagnostic Test: Physical Examination and Questionnaires
Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.




Primary Outcome Measures :
  1. Natural history of treated Eosinophilic Esophagitis (EE) [ Time Frame: approximately 1 year ]
    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.

  2. Natural history of untreated Eosinophilic Esophagitis (EE) [ Time Frame: approximately 1 year ]
    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.

  3. Natural history of treated Eosinophilic Esophagitis (EoE) [ Time Frame: approximately 1 year ]
    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.

  4. Natural history of untreated Eosinophilic Esophagitis (EoE) [ Time Frame: approximately 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eosinophilic Esophagitis patients that we have been following for 10 years and participated in the previous study.
Criteria

Inclusion Criteria:

  • Adults 18 years of age and older
  • Previous participation in the natural history followup study

Exclusion Criteria:

  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290482


Contacts
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Contact: Debra M Geno, CCRP 507-538-0367 geno.debra@mayo.edu
Contact: Cystal J Tholen, CRC 507-538-1361 tholen.crystal@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
Contact: Crystal J. Tholen, CRC    507-538-0367    tholen.crystal@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jeffrey A Alexander, MD Mayo Clinic

Publications:
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Responsible Party: Jeffrey A Alexander, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03290482     History of Changes
Other Study ID Numbers: 17-002067
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases