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OpenTrials
Completed

NCT Number: NCT03290482

Natural History of Eosinophilic Esophagitis

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

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Barium Esophagram

Diagnostic Test

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.

EsophaCap

Device

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 names: Sponge

Physical Examination and Questionnaires

Diagnostic Test

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: EoE

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 25, 2017
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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