Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study

Study Overview
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Brief Summary
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This pilot study will explore whether treatment of eosinophilic inflammation in the esophagus is associated with an improved distensibility of the esophagus. Furthermore, previous studies of the esophagus using EndoFlip only measured distensibility of the distal esophagus, specifically the distal esophagus and esophagogastric junction. Eosinophilia in EoE has been demonstrated to affect both upper, middle and lower esophagus. The aim is to measure distensibility both proximal and distal, before and after treatment.

Official Title
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Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Diagnostic Test: endoflip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Presence of eosinophilia on esophageal biopsy, defined as a peak count of > 15 eosinophils per high power field (HPF) on light microscopy based on biopsies from at least 2 of the 3 biopsy segments (upper, middle and distal esophagus) Exclusion Criteria: Secondary causes of esophageal eosinophilia has been excluded, such as eosinophilic GI diseases, celiac disease, Crohn's disease, esophageal infection, hypereosinophilic syndrome, drug hypersensitivity, vasculitis, pemphigus, connective tissue diseases, graft vs. host disease Age < 18 or > 65 years Contraindication for biopsy, such as presence of esophageal varices, coagulopathy History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia) Pregnancy Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eosinophilic Esophagitis patients<br>PPI treatment | Diagnostic Test: endoflip<br>* Resolution of esophageal eosinophilia by a 2-month course of high dose PPI in patients will lead to improvement in esophageal distensibility, and thus should produce improvement in dysphagia symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Esophageal Distensibility before and after treatment | 1. Measure the changes in esophageal distensibility before and after treatment with PPI in patients with esophageal eosinophilia | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eosinophilia or the number of eosinophils | 4. To correlate changes of esophageal mucosa eosinophilia with changes of lumen distensibility in the different segments of the esophagus | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoflip