Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pol… (NCT06771791) | Clinical Trial Compass
RecruitingPhase 3
Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
France110 participantsStarted 2025-01-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Sub…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome