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

NCT03312686 | Recruiting

• 1 other identifier: EOE-endoflip
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Eosinophilic Esophagitis

Keywords

endoflip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in eosinophilia or the number of eosinophils

  2 months

Study Arms (1)

Eosinophilic Esophagitis patients

PPI treatment

Diagnostic Test: endoflip

Interventions

endoflip 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.

Eosinophilic Esophagitis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You 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 may not qualify 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Akiro Saito, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Schilling

CONTACT

maschi@iu.edu

Lainna Cohen

CONTACT

3172780621; larcohen@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: October 18, 2017
• Study Start: November 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)