Natural History of Eosinophilic Esophagitis

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Diagnostic Test: Barium Esophagram; Device: EsophaCap; Diagnostic Test: Physical Examination and Questionnaires

• Registration Number: NCT03290482
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-25
• Primary Completion: 2019-11-01
• Study Completion: 2020-03-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EE Study Patients 2000-2008	Barium Esophagram	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
EE Study Patients 2000-2008	Physical Examination and Questionnaires	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
EE Study Patients 2000-2008	EsophaCap	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

Primary Outcome Measures

Name	Time	Method
Natural history of treated Eosinophilic Esophagitis (EE)	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.
Natural history of untreated Eosinophilic Esophagitis (EE)	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.
Natural history of treated Eosinophilic Esophagitis (EoE)	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.
Natural history of untreated Eosinophilic Esophagitis (EoE)	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States