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

Launched by INDIANA UNIVERSITY · Oct 12, 2017

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Endoflip

ClinConnect Summary

This clinical trial is investigating how treatment with proton pump inhibitors (medications that reduce stomach acid) affects the ability of the esophagus to stretch and expand in patients with eosinophilic esophagitis (EoE). EoE is a condition where the esophagus becomes inflamed due to a high number of eosinophils, a type of white blood cell. This study aims to measure how well different parts of the esophagus can expand before and after treatment, as previous research has mostly focused on just the lower part of the esophagus.

To participate in this trial, you must be between 18 and 65 years old and have been diagnosed with eosinophilia, which means your esophagus has a high count of eosinophils based on biopsy results. You should not have other underlying conditions that could cause this eosinophilia, nor should you have had major esophageal surgery or have any serious health issues that would prevent a biopsy. If you decide to join, you can expect to undergo evaluations of your esophagus’s distensibility before and after treatment, helping researchers understand how effective the therapy is in improving this condition.

Gender

ALL

Eligibility criteria

  • 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:
  • 1. 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
  • 2. Age \< 18 or \> 65 years
  • 3. Contraindication for biopsy, such as presence of esophageal varices, coagulopathy
  • 4. History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia)
  • 5. Pregnancy
  • 6. Prisoners

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Akiro Saito, MD

Principal Investigator

Indiana University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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