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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
StatusRecruiting
PhasePhase 3
Started2025-01-08
View on ClinicalTrials.gov ↗

Amendment history

2026-05-20
minor
Study Identification, Study Status, Oversight, Study Design, Contacts/Locations v2
Study sites1→4
Study titlerevised
Evaluation of the Efficacy of Oral Immunotherapy withWith Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
2025-01-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-01-07
minor
Original filing
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.
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