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

Recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Diagnostic Test: endoflip

• Registration Number: NCT03312686
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eosinophilic Esophagitis patients	endoflip	PPI treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States