Eating With Eosinophilic Esophagitis (EoE)

Eating Behavior in Patients With Eosinophilic Esophagitis.

Is there a difference in the eating process for patients with active Eosinophilic Esophagitis (EoE) and those with inactive disease?

Study Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis (EoE)
• Intervention / Treatment: Behavioral: Observed eating session

Detailed Description

Eosinophilic esophagitis (EoE) patients develop adapted eating behaviors to prevent symptoms. These patients tend to cut their food small, chew extensively, take copious liquids with meals, and avoid foods that cause symptoms. No studies to date have directly evaluated these eating behaviors in patients with EoE with observation. Furthermore, none of the investigators' current metrics for patient symptom assessment visually evaluate the eating process nor are they compared before and after treatment. As a result, it is unclear if a patient's subjective perception of their eating difficulties and improvement matches with objective measures.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals with EoE that are being seen at Mayo Clinic Esophageal Clinic will be approached. Controls will be individuals who do not have an EoE diagnosis.

Description

Inclusion Criteria:

• 18 years of age and older
• Patients suspected to have Eosinophilic Esophagitis
• Patients being treated for EoE with PPI or a steriod
• EoE patients that are in remission by having less than 22 on the EEsAI questionnaire
• Controls, patients that do not have EoE or other swallowing issues

Exclusion Criteria:

• Clinical evidence of infectious process potentially contributing to dysphagia (candidiasis, CMV,herpes)
• Other cause of dysphagia identified at endoscopy (reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
• EoE patients that do not eat sandwiches or feel they could not eat a sandwich.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acitve EoE; Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals who have EoE who have not been treated or have not achieved remission from treatment.	Behavioral: Observed eating session; Eating a Jimmy Johns turkey or vegetarian sandwich
Remission EoE; Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals who have EoE who are have achieved remission from treatment.	Behavioral: Observed eating session; Eating a Jimmy Johns turkey or vegetarian sandwich
Controls; Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals without EoE.	Behavioral: Observed eating session; Eating a Jimmy Johns turkey or vegetarian sandwich

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed eating session	number of bites of patient's with EoE and controls eating a Jimmy John's sandwich	15-90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food slowness during eating session	number of bites that felt stuck among patients with EoE and controls when eating a Jimmy John's sandwich	15-90 minutes
Water during eating session	amount of water drank of patients with EoE and controls eating a Jimmy John's sandiwch	15-90 minutes
Eosinophilic Esophagitis activity Index (EEsAI) questionnaire	The EEsAI Pro uses the VDQ is visual dysphagia question AMS is avoidance, modification, slow eating question . These two along with questions on frequency of, duration of, pain associated with dysphagia make up the PRO (patient reported outcomes). The PRO is a number (0-100) calculated from the answer to the questions. A PRO < 20 defines asymptomatic EoE.	10-15 minutes
Eosinophilic Esophagitis Quality of Life questionnaire	Higher score denote better quality of life. 0-4 as follows 4=not at all, 3=Slightly 2=moderately, 1=Quite a bit, 0= Extremely	10-15 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jeffrey A Alexander, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Actual): July 23, 2019
• Study Completion (Actual): July 23, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Dysphagia; EoE
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: 18-002628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No