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

NCT ID: NCT03312686

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Eosinophilic Esophagitis patients

PPI treatment

endoflip

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Akira Saito

Assistant Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akiro Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maureen Schilling

Role: CONTACT

maschi@iu.edu

Lainna Cohen

Role: CONTACT

larcohen@iu.edu

3172780621

Facility Contacts

Maureen Schilling

Role: primary

maschi@iu.edu

Other Identifiers

EOE-endoflip

Identifier Type: -

Identifier Source: org_study_id