Behandeling met een op maat gemaakt dieet bij eosinofiele oesofagitis: De IDEA-studie”

Recruiting

• Conditions: Eosinophilic oesophagitis, food allergy, diet, ImmunoCAP ISAC, serum IgE.Eosinofiele oesofagitis, voedselallergie, dieet, ImmunoCAP ISAC, serum IgE.

• Registration Number: NL-OMON27096
• Lead Sponsor: Academic Medical Center, Amsterdam, The Netherlands

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• 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 (microarray)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak eosinophilia in mucosal biopsies of proximal, mid- and distal oesophagus at baseline and after targeted dietary treatment defined as complete (peak eosinophil count, <5 eos/hpf), near complete (<10 eos/hpf), and partial (>50% reduction of peak eosinophil count).

Secondary Outcome Measures

Name	Time	Method
• Symptoms of dysphagia;<br /><br>• Quality of life, as measured by the SF-36 and the FAQLQ-AF questionnaire;<br /><br>• Endoscopic signs of EoO;<br /><br>• Peak mastocytosis in mucosal biopsies of proximal, mid- and distal oesophagus;<br /><br>• Serum levels of biomarkers for EoO: eosinophil count, total IgE, IL-5, IL-13, eotaxin-3, eosinophil derived neurotoxin (EDN);<br /><br>• RNA-expression of biomarkers for EoO in oesophageal tissue;<br /><br>• Evaluation of dietary intake at baseline of EoO-patients<br /><br>• Comparison of results of the ImmunoCAP ISAC allergy test with standard skin prick test results.