Clinical Trial

Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

Study acronym: ELIO
Recruiting Phase 3
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Summary
Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-07; most recent amendment 2026-05-20.
Status change: Not Yet Recruiting → Recruiting 2025-01-23
Trial Details
NCT Number NCT06771791
Lead Sponsor University Hospital, Strasbourg, France
Conditions Allergies
Enrollment 110 participants
Start Date 2025-01-08
Primary Completion 2027-05-05 (estimated)
Study Completion 2027-05-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-26