Individually tailored Dietary treatment of Eosinophilic oesophagitis in Adults

Completed

Conditions: allergic esophagitis
Eosinophilic esophagitis
10017969
10001708

Registration Number: NL-OMON39630

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

* Previous clinical diagnosis of EoO confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in mid- or proximal-oesophageal biopsies
* (Cross-)sensitization against at least 1 food allergen as measured by ImmunoCAP ISAC
* Age 18-75 years
* Written informed consent

Exclusion Criteria

* Inability to stop previously started topical or systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the two month period preceding and during the study
* Use of NSAIDs
* History of peptic ulcer disease
* History of Barrett*s oesophagus
* History of GI cancer
* History of GI tract surgery (except appendectomy or cholecystectomy)
* ASA class IV or V

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Oesophageal eosinophilic infiltration at baseline and after dietary treatment,<br /><br>and after reintroduction of foods, as measured by the peak eosinophil count in<br /><br>the oesophageal mucosa. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Symptoms of dysphagia and quality of life (SF-36 and the FAQLQ-AF<br /><br>questionnaire), endoscopic signs of EoO, oesophageal mastocytic infiltration,<br /><br>serum levels of biomarkers for EoO (eosinophil count, total IgE, IL-5, IL-13,<br /><br>eotaxin-3, eosinophil derived neurotoxin [EDN]), oesophageal tissue biomarkers<br /><br>(e.g. IL-5, IL-13, eotaxin-3, periostin, TGF-bèta, filaggrin, phospho-MLCK).<br /><br>Validation of results of the ImmunoCAP ISAC allergy test compared to standard<br /><br>skin prick test results.</p><br>