Clinical Trials

Eating With Eosinophilic Esophagitis (EoE)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03581838
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jeffrey A Alexander
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis (EoE)

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

: Controls

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

Interventions

Behavioral: - Observed eating session

Eating a Jimmy Johns turkey or vegetarian sandwich

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Debra M. Geno, CCRP

geno.debra@mayo.edu

507-538-0367

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