Oral immunotherapy with raw apple for birch pollen and apple allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of oral immunotherapy using raw apple in patients who are allergic to both birch pollen and raw apple. The study aims to improve the management of these allergies by helping patients develop tolerance to raw apple and potentially other related foods. It involves a multicenter, comparative approach and includes an oral provocation test to assess patient responses. The trial is designed to provide more robust evidence compared to previous studies by including a control group and double-blind evaluations.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France, France Recruiting
• Hopital François Mitterrand Chu Dijon
  Dijon, France Recruiting
• Chu Jean Minjoz
  Besançon, France Not yet recruiting
• Hopital Maison Blanche Chu Reims
  Reims, France Not yet recruiting

Study contacts

• Study coordinator: Anays PIOTIN, Dr
• Email: anays.piotin@chru-strasbourg.fr
• Phone: +33 03.69.55.00.49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.