A Phase 3 interventional study of oral provocation test in Allergies, sponsored by University Hospital, Strasbourg, France. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University Hospital, Strasbourg, France · Phase 3, Interventional, and Treatment
Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 110 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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oral immunotherapy with raw apple during 9 month
Other: oral provocation test
avoidance of raw apples for 9 months
Other: oral provocation test
Progressively increasing doses of peeled fresh Golden apple or placebo will be consumed by the patient (4g, 12g, 40g, 120g) with a time interval of 20 minutes between each dose.
Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome
To evaluate the efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome after 9 months of oral immunotherapy. A reduction in oral syndrome after 9 months of oral immunotherapy with raw apple is defined as: absence of oral syndrome on the 9-month raw apple OPT when consuming a dose of raw apple 3 times greater than the dose of raw apple triggering oral syndrome on the initial raw apple oral challenge.
Time frame: 9 month
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for May 2027, 27 months after the start.
Of 42 phase 3 interventional studies under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 27 months is above that.
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University Hospital, Strasbourg, France →