RecruitingPhase 3NCT06771791

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

Sponsor

University Hospital, Strasbourg, France

Enrollment

110 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Allergies

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Patient with allergic rhinitis to birch pollen.
Patient with an oral syndrome within 15 minutes of consuming at least one of the first 3 doses of raw apple in the V0 or V1 raw apple oral challenge test.
Evidence of sensitization to PR10 proteins in birch pollen and apple: positive prick tests to birch pollen and raw Golden apple and/or positive Bet v 1 and Mal d 1 specific IgE assays.
Subject affiliated to a social health insurance scheme
Subject able to understand the aims and risks of the research and to give dated and signed informed consent
For women of childbearing age: negative urine pregnancy test at inclusion visit

Exclusion Criteria18

Severe or uncontrolled asthma
Severe obstructive syndrome
Active neoplastic disease
Active autoimmune disease
Eosinophilic esophagitis or other active eosinophilic gastrointestinal pathologies
History of bariatric surgery
History of anaphylaxis to apples
Allergy to cooked apples
Contraindication to anti-histamines, corticoids, salbutamol, adrenaline
Other contraindication to an oral challenge test
Allergy to placebo ingredients
Presence of oral syndrome during consumption of placebo in the first oral challenge test
Allergenic immunotherapy to birch pollen in progress or completed less than 5 years ago
Current treatment with anti-IgE, anti-IL4/13, anti-IL5 or anti-TSLP biotherapy.
Impossibility of giving the subject informed information
Subject under court protection
Subject under guardianship or curatorship
Pregnancy

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Interventions

OTHERoral provocation test

Progressively increasing doses of peeled fresh Golden apple or placebo will be consumed by the patient (4g, 12g, 40g, 120g) with a time interval of 20 minutes between each dose.