Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single- centred randomised prospective study

Phase 3

• Conditions: eosinophilic esophagitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12619000141145
• Lead Sponsor: Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-30
• Last Update Posted: 4 February 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Adults over the age of 18 with a diagnosis of eosinophilic esophagitis defined by consensus guidelines (symptoms of oesophageal dysfunction + more than or equal to 15 eosinophils / high powered field on oesophageal biopsies despite 8 weeks of treatment with PPIs to exclude PPI responsive eosinophilia) who were naïve for topical steroid or dietary therapy.

Exclusion Criteria

•Patients with potential cause for eosinophilia different from eosinophilic esophagitis (e.g. achalasia, caustic or radiation esophagitis, parasites, Inflammatory Bowel Disease, neoplasms and drugs)
•patients with food associated anaphylaxis to milk and wheat
•patients with severe fibro-stricturing eosinophilic esophagitis
•patients in whom esophageal biopsies would be contraindicated (presence of varices or anti coagulation / anti platelets at high risk of thrombotic/ cardio vascular event if withheld)
•Patients who are on oral or inhaled steroids for other indication will be excluded from this study.
•Patients who lack capacity to provide written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified