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

November 21, 2025 updated by: Akira Saito, Indiana University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
        • Contact:
        • Principal Investigator:
          • Akiro Saito, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the clinic and endoscopy who are undergoing endoscopy with endoflip

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eosinophilic Esophagitis patients
PPI treatment
Diagnostic test: endoflip
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Esophageal Distensibility before and after treatment
Time Frame: 2 months
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
Time Frame: 2 months
4. To correlate changes of esophageal mucosa eosinophilia with changes of lumen distensibility in the different segments of the esophagus
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Akiro Saito, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOE-endoflip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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