Natural History of Eosinophilic Esophagitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03290482

Acronym

EoE

Enrollment

Registered

2017-09-25

Start date

2017-06-19

Completion date

2020-03-25

Last updated

2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

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.

Interventions

DIAGNOSTIC_TESTBarium 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.

DEVICEEsophaCap

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)

DIAGNOSTIC_TESTPhysical 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026