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

Eosinophilic Esophagitis Clinical Trial

— EOE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312686
• Other study ID #: EOE-endoflip
• Status: Recruiting
• Start date: November 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: Anita Gupta, MBBS
• Phone: 3179489227
• Email: anigupta[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilia
• Eosinophilic Esophagitis
• Esophagitis

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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