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CompletedNCT03581838Updated Oct 9, 2019

Eating With Eosinophilic Esophagitis (EoE)

An observational study in Eosinophilic Esophagitis (EoE), sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
31
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Eosinophilic Esophagitis (EoE)

Keywords

  • EoE
  • Dysphagia
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 31 is below the median of 100 across 91 observational studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • Controls

    Observed eating session of Jimmy John's turkey or vegetarian sandwich with water among individuals without EoE.

    Behavioral: Observed eating session

Interventions

  • BehavioralObserved eating session

    Eating a Jimmy Johns turkey or vegetarian sandwich

06

What researchers measure

Primary outcomes

  1. Observed eating session

    number of bites of patient's with EoE and controls eating a Jimmy John's sandwich

    Time frame: 15-90 minutes

Secondary outcomes

  1. Food slowness during eating session

    number of bites that felt stuck among patients with EoE and controls when eating a Jimmy John's sandwich

    Time frame: 15-90 minutes

  2. Water during eating session

    amount of water drank of patients with EoE and controls eating a Jimmy John's sandiwch

    Time frame: 15-90 minutes

  3. 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.

    Time frame: 10-15 minutes

  4. 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

    Time frame: 10-15 minutes

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03581838
Lead sponsor
Mayo Clinic
Responsible party
Jeffrey A Alexander (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 10, 2018
Start date
May 24, 2018
Primary completion
Jul 23, 2019
Completion
Jul 23, 2019
Last update
Oct 9, 2019

Study contacts

Jeffrey A Alexander
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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