EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT03781596

Run by

Claire Daniels

People needed

100

Starts

2018-10-02

Expected to finish

2022-10-02

Last updated by the study team

2018-12-20

Who can join

Age: 6 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 6 to 60 years old
• DEERS (defense enrollment eligibility reporting system) eligible
• diagnosis of eosinophilic esophagitis

You may not qualify if…

• 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

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.