NCT03581838

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

June 11, 2018

Last Update Submit

October 8, 2019

Conditions

Keywords

EoEDysphagia

Outcome Measures

Primary Outcomes (1)

  • Observed eating session

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

    15-90 minutes

Secondary Outcomes (4)

  • Food slowness during eating session

    15-90 minutes

  • Water during eating session

    15-90 minutes

  • Eosinophilic Esophagitis activity Index (EEsAI) questionnaire

    10-15 minutes

  • Eosinophilic Esophagitis Quality of Life questionnaire

    10-15 minutes

Study Arms (3)

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

Eating a Jimmy Johns turkey or vegetarian sandwich

Acitve EoEControlsRemission EoE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic EsophagitisDeglutition Disorders

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jeffrey A Alexander

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 10, 2018

Study Start

May 24, 2018

Primary Completion

July 23, 2019

Study Completion

July 23, 2019

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations