EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone
Eosinophilic Esophagitis
About this trial
This is an interventional other trial for Eosinophilic Esophagitis
Eligibility 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
Sites / Locations
- Walter Reed National Military Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Fluticasone and omeprazole
Fluticasone and placebo
These patients will be prescribed swallowed fluticasone and omeprazole to be taken together for the 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.
These patients will be prescribed swallowed fluticasone and a placebo medication that appears identical to omeprazole to be taken together for an 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.