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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03312686

Acronym

EOE

Enrollment

Registered

2017-10-18

Start date

2016-11-30

Completion date

2026-12-31

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

endoflip

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.

Interventions

DIAGNOSTIC_TESTendoflip

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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Esophageal Distensibility before and after treatment	2 months	1\. Measure the changes in esophageal distensibility before and after treatment with PPI in patients with esophageal eosinophilia

Secondary

Measure	Time frame	Description
Change in eosinophilia or the number of eosinophils	2 months	4\. To correlate changes of esophageal mucosa eosinophilia with changes of lumen distensibility in the different segments of the esophagus

Countries

United States

Contacts

Primary ContactMaureen Schilling

maschi@iu.edu

Backup ContactLainna Cohen

larcohen@iu.edu3172780621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026