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Apple a day keeps the allergy away? new trial tests raw apple therapy

NCT ID NCT06771791

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Chu Jean Minjoz

    NOT_YET_RECRUITING

    Besançon, 25030, France

  • Hopital François Mitterrand Chu Dijon

    RECRUITING

    Dijon, 21079, France

  • Hopital Maison Blanche Chu Reims

    NOT_YET_RECRUITING

    Reims, 51092, France

  • Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, France, 67000, France

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