Apple a day keeps the allergy away? new trial tests raw apple therapy
NCT ID NCT06771791
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether eating small, increasing amounts of raw apple can reduce mouth allergy symptoms in people who are allergic to both birch pollen and apples. 110 participants will eat either real apple or a placebo over 9 months. The goal is to see if they can tolerate a larger dose of apple without symptoms, potentially offering a simple treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- raw apple
- What this could lead to
- If it works, this could offer a practical way for people with birch-apple allergy to eat raw apples without mouth itching or swelling, improving their quality of life.
- What could go wrong
- This is a Phase 3 trial, but the treatment is simply eating apple, so the effect may be modest. Allergic reactions during the test are possible, and results may not apply to all apple varieties or other related fruits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chu Jean Minjoz
NOT_YET_RECRUITINGBesançon, 25030, France
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Hopital François Mitterrand Chu Dijon
RECRUITINGDijon, 21079, France
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Hopital Maison Blanche Chu Reims
NOT_YET_RECRUITINGReims, 51092, France
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Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, France, 67000, France
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