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ACTIVE NOT RECRUITING
NCT04149470
PHASE4

Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This study will enroll participants who have been diagnosed with Eosinophilic Esophagitis (EoE). Upon study enrollment, the participant will begin a proton pump inhibitor (PPI), Omeprazole 20mg twice daily. After taking Omeprazole for four weeks, the participant will have a Transnasal Endoscopy, and biopsies will be taken to determine the histological change. If the biopsies are abnormal, the participant continues Omeprazole and will undergo another endoscopy at eight weeks. The study aims to determine the percentage of children with Eosinophilic Esophagitis who improve with PPI use and to determine the length of time and effectiveness of PPI therapy in the management of EoE. The investigators hypothesize that following the initiation of PPI for treatment of Eosinophilic Esophagitis, biopsies obtained will show decreasing eosinophil counts at four weeks, which is sooner than the previously reported eight-week period.

Key Details

Gender

All

Age Range

8 Years - 22 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2020-10-07

Completion Date

2024-08

Last Updated

2024-07-03

Healthy Volunteers

No

Interventions

DRUG

Omeprazole 20mg BID

High dose PPI therapy (Omeprazole 20mg twice daily)

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States