Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral provocation test.
- Who it may be relevant to
- Registry conditions: Allergies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome [Time frame: 9 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 4 centers
- Hôpitaux Universitaires de Strasbourg — Strasbourg
- Chu Jean Minjoz — Besançon
- Hopital François Mitterrand Chu Dijon — Dijon
- Hopital Maison Blanche Chu Reims — Reims
Identifiers
NCT: NCT06771791 · 9432