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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2027-05-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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oral immunotherapy

oral immunotherapy with raw apple during 9 month

Group Type EXPERIMENTAL

oral provocation test

Intervention Type OTHER

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.

eviction

avoidance of raw apples for 9 months

Group Type PLACEBO_COMPARATOR

oral provocation test

Intervention Type OTHER

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.

Interventions

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oral 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No