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Eating With Eosinophilic Esophagitis (EoE)

Eating Behavior in Patients With Eosinophilic Esophagitis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03581838
Enrollment
31
Registered
2018-07-10
Start date
2018-05-24
Completion date
2019-07-23
Last updated
2019-10-09

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

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

EoE, Dysphagia

Brief summary

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

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.

Interventions

BEHAVIORALObserved eating session

Eating a Jimmy Johns turkey or vegetarian sandwich

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Observed eating session15-90 minutesnumber of bites of patient's with EoE and controls eating a Jimmy John's sandwich

Secondary

MeasureTime frameDescription
Food slowness during eating session15-90 minutesnumber of bites that felt stuck among patients with EoE and controls when eating a Jimmy John's sandwich
Water during eating session15-90 minutesamount of water drank of patients with EoE and controls eating a Jimmy John's sandiwch
Eosinophilic Esophagitis activity Index (EEsAI) questionnaire10-15 minutesThe 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.
Eosinophilic Esophagitis Quality of Life questionnaire10-15 minutesHigher score denote better quality of life. 0-4 as follows 4=not at all, 3=Slightly 2=moderately, 1=Quite a bit, 0= Extremely

Countries

United States

Outcome results

None listed

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