Effect of addition of elemental nutrition to an elimination diet on esophageal inflammation in adult eosinophilicesophagitis (EoE) patients: A randomized controlled trial
- Conditions
- Eosinophilic oesofagitisElimination dietElemental supplementEsophageal inflammationIn het NederlandsEosinofiele oesofagitisEliminatie dieetElementair supplementOesofagiale inflammatie
- Registration Number
- NL-OMON24372
- Lead Sponsor
- Academic Medical Center (AMC) Amsterdam. Dept. Gastroenterology & Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Active EoE at baseline i.e. presence of >15 eosinophilic granulocytes per high power field (HPF) in mid or proximal esophageal biopsies before the start of any therapy
- Currently experiencing dysphagia
Exclusion Criteria
- Inability to stop topical corticosteroids
- Use of systemic corticosteroids, leuko triene inhibitors, or monoclonal antibodies, in the month preceding the
study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in peak eosinophil count, measured as maxi mum number of eosinophils per HPF. Response is defined as complete if the<br>reduction of absolute number of eosinophils per HPF is decreased to <10 eosinophils/HPF. Esophageal mucosal eosinophil<br>infiltration is considered the most important marker of disease activity and is primary endpoint in all major therapeutic studies. These<br>biopsies are taken at mid and proximal esophageal level during upper endoscopy.
- Secondary Outcome Measures
Name Time Method