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OpenTrials
Completed

NCT Number: NCT03581838

Eating With Eosinophilic Esophagitis (EoE)

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Observed eating session

Behavioral

Eating a Jimmy Johns turkey or vegetarian sandwich

Primary outcomes

  1. Observed eating session

    Time frame: 15-90 minutes

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

Secondary outcomes

  1. Food slowness during eating session

    Time frame: 15-90 minutes

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

  2. Water during eating session

    Time frame: 15-90 minutes

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

  3. Eosinophilic Esophagitis activity Index (EEsAI) questionnaire

    Time frame: 10-15 minutes

    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.

  4. Eosinophilic Esophagitis Quality of Life questionnaire

    Time frame: 10-15 minutes

    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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Eating Behavior in Patients With Eosinophilic Esophagitis.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2018
Registry last updated
Oct 9, 2019

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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