Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Indiana University
10 participants
Nov 1, 2016
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- \. 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 Criteria6
- 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
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT03312686