Oral immunotherapy with raw apple for birch pollen and apple allergies
Evaluation of the Efficacy of Oral Immunotherapy with Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
This study is testing if eating raw apple can help people who are allergic to both birch pollen and raw apple build up a tolerance to these allergens.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Strasbourg, France) |
| Trial ID | NCT06771791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with allergic rhinitis to birch pollen who experience oral symptoms after consuming raw apple.
Not a fit: Patients with severe asthma, active neoplastic or autoimmune diseases, or a history of anaphylaxis to apples may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients suffering from apple-birch pollen-food allergy syndrome by allowing them to safely consume raw apples.
How similar studies have performed: Previous studies on oral immunotherapy for food allergies have shown promise, but this specific approach using raw apple is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Strasbourg, France
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France, France (Recruiting)
Study contacts
- Study coordinator: Anays PIOTIN, Dr
- Email: anays.piotin@chru-strasbourg.fr
- Phone: +33 03.69.55.00.49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.