Natural History of Eosinophilic Esophagitis

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

Sponsors

Lead Sponsor: Mayo Clinic

Source 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.

Overall Status Recruiting
Start Date June 19, 2017
Completion Date December 1, 2021
Primary Completion Date July 1, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Natural history of treated Eosinophilic Esophagitis (EE) approximately 1 year
Natural history of untreated Eosinophilic Esophagitis (EE) approximately 1 year
Natural history of treated Eosinophilic Esophagitis (EoE) approximately 1 year
Natural history of untreated Eosinophilic Esophagitis (EoE) approximately 1 year
Enrollment 65
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Barium Esophagram

Description: 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.

Arm Group Label: EE Study Patients 2000-2008

Intervention Type: Device

Intervention Name: EsophaCap

Description: 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)

Arm Group Label: EE Study Patients 2000-2008

Other Name: Sponge

Intervention Type: Diagnostic Test

Intervention Name: Physical Examination and Questionnaires

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

Arm Group Label: EE Study Patients 2000-2008

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jeffrey A Alexander, MD Principal Investigator Mayo Clinic
Overall Contact

Last Name: Debra M Geno, CCRP

Phone: 507-538-0367

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Mayo Clinic Debra M. Geno, CCRP 507-538-0367 [email protected]
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: Jeffrey A Alexander

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Arm Group

Label: EE Study Patients 2000-2008

Description: 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

Acronym EoE
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov