Natural History of Eosinophilic Esophagitis

Completed

• Conditions: Eosinophilic Esophagitis

• 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

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