EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

• Status: Recruiting
• Trial end date: 2022-10-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized controlled trial. The primary outcome measured will be histologic assessment of esophageal tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary outcomes will be endoscopic findings and symptomatic changes following therapy using validated endoscopic scoring measures and participant surveys, respectively.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Claire Daniels
• Treatments: Fluticasone; Omeprazole

Criteria

Inclusion Criteria:

• age 6 to 60 years old

• DEERS (defense enrollment eligibility reporting system) eligible

• diagnosis of eosinophilic esophagitis

Exclusion Criteria:

• Outside of age range

• Co-existing inflammatory gastroenterologic condition such as celiac disease, eosinophilic esophagitis, or inflammatory bowel disease.

• Concurrent use of oral steroids

• Pregnancy

• Refusal to undergo endoscopy