Evaluation of the Efficacy of Oral Immunotherapy with Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who have allergies related to birch pollen and raw apples. Specifically, it is looking at whether oral immunotherapy with raw apple can help patients become tolerant to eating apples, potentially improving their quality of life. Currently, the main way to manage this allergy is by avoiding certain foods, which isn’t always effective. This trial aims to see if eating small amounts of raw apple can help patients build up their tolerance over time.

To be eligible for this study, participants should be adults who experience allergic reactions, such as oral discomfort, after eating raw apple and have a known allergy to birch pollen. Participants must also be able to understand the study and provide consent. During the trial, participants will consume raw apple under medical supervision and will be monitored for their reactions. This trial is currently recruiting participants, and it’s important for anyone considering joining to discuss any existing health conditions with their doctor to ensure they meet the necessary criteria.

Gender

ALL

Eligibility 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