EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Subjects that meet study inclusion criteria will be recruited from the Adult and Pediatric
Gastroenterology clinics at Walter Reed National Military Medical Center through routine
clinic visits, will meet with an investigator, and complete informed consent/assent. The
participants will then complete a validated clinical symptom reporting tool - the
Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the
Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs - and have their initial
Esophagogastroduodenoscopy (EGD) images evaluated via a validated Endoscopic Reference Score
(EREFS). Esophageal biopsies taken at the patient's initial EGD will be assessed by 2
designated blinded pathologists to record the number of eosinophils per high power field
(HPF), as well as perform tissue immunohistochemical staining for eotaxin-3. Participants
will be block randomized to treatment or control groups and complete 8 weeks of therapy, with
a phone follow up at 4 weeks for medication compliance. At the completion of 8 weeks of
therapy, the participants will have repeat EGD to assess for mucosal healing, which is the
standard of care in the treatment of EoE. At this EGD, the images will be assigned an EREFS
and the biopsies will be evaluated for eosinophils per high powered field and eotaxin-3
staining. The patient will also complete an EEsAI or PedsQL. This procedure will end the 8
week study period.

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