Natural History of Eosinophilic Esophagitis

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

Detailed Description
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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.

Official Title
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Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Diagnostic Test: Barium Esophagram
* Device: EsophaCap
* Diagnostic Test: Physical Examination and Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EE Study Patients 2000-2008<br>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 | Diagnostic Test: Barium Esophagram<br>* 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.<br>Device: EsophaCap<br>* 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)<br>* Other names: Sponge;Diagnostic Test: Physical Examination and Questionnaires<br>* Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of treated Eosinophilic Esophagitis (EE) | 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. | approximately 1 year | 
| Natural history of untreated Eosinophilic Esophagitis (EE) | 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. | approximately 1 year | 
| Natural history of treated Eosinophilic Esophagitis (EoE) | 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. | approximately 1 year | 
| Natural history of untreated Eosinophilic Esophagitis (EoE) | 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. | approximately 1 year |