*Effect of addition of elemental nutrition to an elimination diet on esophageal inflammation in adult eosinophilic esophagitis (EoE) patients: A randomized controlled trial

Completed

• Conditions: 10017969; allergic esophagitis; Idiopathic eosinophilic esophagitis; 10001708

• Registration Number: NL-OMON48882
• Lead Sponsor: Maag- Darm- en Levergeneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• 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
- Written informed consent
- Age above 18 years

Exclusion Criteria

Patients:
- Inability to stop topical corticosteroids
- Use of systemic corticosteroids, leukotriene inhibitors, or monoclonal
antibodies, in the month preceding the study
- Use of anticoagulants at study entry
- Recent history of GI cancer
- History of major GI tract surgery
- ASA class IV or V

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in peak eosinophil count, measured as maximum number of eosinophils per<br /><br>HPF. Response is defined as complete if the reduction of absolute number of<br /><br>eosinophils per HPF is decreased to <10 eosinophils/HPF. Esophageal mucosal<br /><br>eosinophil infiltration is considered the most important marker of disease<br /><br>activity and is primary endpoint in all major therapeutic studies. These<br /><br>biopsies are taken at mid and proximal esophageal level during upper endoscopy. </p><br>