What this study is
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.
What's being tested
- endoflip
Intervention · DIAGNOSTIC TEST
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.
Study details
- Sponsor
- Indiana University
- Conditions
- Eosinophilic Esophagitis
- Enrolling
- 10 people
- Starts
- 2016-11
- Est. completion
- 2026-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openIndiana University Health University Hospital
Indianapolis, Indiana, United States
- Maureen Schilling · Contactmaschi@iu.edu
- Akiro Saito, MD · Principal investigator
RecruitingIndiana University
Indianapolis, Indiana, United States
Recruiting
Study team
Sponsor
Indiana University
Study ID EOE-endoflip
Principal investigator
Akiro Saito, MD
Indiana University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.