Omeprazole for Eosinophilic Esophagitis

Recruiting in Palo Alto (17 mi)

Overseen by Nathalie Nguyen, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nathalie Nguyen, MD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

This trial is for children and young adults aged 8-22 who have been diagnosed with Eosinophilic Esophagitis (EoE) within the last six months. Participants must weigh over 20kg, be able to swallow pills or take medication with apple sauce, and be willing to undergo a transnasal endoscopy without sedation. Those with bleeding disorders, recent steroid treatments, nasal passage issues, GI illnesses, pregnancy plans or allergies to PPIs cannot join.

Inclusion Criteria

Provide signed and dated informed consent form

I was diagnosed with Eosinophilic Esophagitis in the last 6 months.

I am willing to have a nose scope without sedation.

Exclusion Criteria

Allergy to PPI

I have a diagnosed bleeding disorder.

I expect to change my corticosteroid medication soon.

Treatment Details

Interventions

• Omeprazole (Proton Pump Inhibitor)

Trial Overview The study tests if Omeprazole (a proton pump inhibitor), taken twice daily at a dose of 20mg for four weeks followed by an endoscopic biopsy can improve EoE symptoms in children. If initial biopsies are abnormal after four weeks of treatment, participants continue taking Omeprazole until another check-up at eight weeks.

Participant Groups

Group I: Omeprazole Experimental Treatment 1 Intervention

Participants will receive high dose PPI therapy (Omeprazole 20mg twice daily) and will be evaluated for histological improvement.

Omeprazole is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Omez for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in Japan as Omeprazole for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in China as Omeprazole for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in Switzerland as Omeprazole for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Jena Hausmann

Children's Hospital Colorado

Chief Executive Officer since 2015

Master’s degree in Healthcare Administration from the University of Minnesota, B.A. in Political Science from Colorado College

David Brumbaugh

Children's Hospital Colorado

Chief Medical Officer since 2024

MD