Eating With Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis (EoE) Clinical Trial

Official title:

Eating Behavior in Patients With Eosinophilic Esophagitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581838
• Other study ID #: 18-002628
• Status: Completed
• Start date: May 24, 2018
• Est. completion date: July 23, 2019

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Eosinophilic Esophagitis (EoE)
• Esophagitis

Intervention

Behavioral:
• Observed eating session
Eating a Jimmy Johns turkey or vegetarian sandwich

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed eating session	number of bites of patient's with EoE and controls eating a Jimmy John's sandwich	15-90 minutes
Secondary	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
Secondary	Water during eating session	amount of water drank of patients with EoE and controls eating a Jimmy John's sandiwch	15-90 minutes
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials