This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet. The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group. Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.
Age 1-12 years;
Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and/or tree nuts: cashew, walnut, hazelnut, and almond;
Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and/or specific IgE (sIgE) level > 0.35 kUA/L for at least two of the analyzed allergens;
Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein;
Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;
History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;
Severe asthma;
Poorly controlled asthma according to GINA 2025 (lack of symptom control and/or ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 < -1.64 Z-score and/or FEV1/FVC < -1.64 Z-score;
Parallel
Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins
Other interventionMulti-food oral immunotherapy using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond), administered in a dose-escalation phase followed by a maintenance phase with a target daily dose of 300 mg of protein per allergen.
Standard of Care (Elimination Diet)
Other interventionStandard management consisting of strict dietary avoidance of peanut and tree nuts, along with the use of rescue medications, including epinephrine, in the event of accidental allergen exposure.
Immunotherapy Efficacy
Evaluation of immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group.
Proportion of Participants Tolerating at least 2, 3, 4 or 5 Allergens at a Cumulative Dose of 4444 mg During OFC-2
Proportion of participants who tolerate a cumulative dose of 4444 mg of protein for at least 2, 3, 4, or 5 allergens during OFC-2 (post-treatment oral food challenge). Tolerance is defined as consumption of the full cumulative dose without dose-limiting allergic symptoms. The outcome will be summarized as the proportion of participants meeting each threshold and compared between study groups.
Change in Maximum Tolerated Allergen Dose from OFC-1 to OFC-2
Change in the maximum tolerated dose (mg of protein) of allergens during oral food challenge from OFC-1 (baseline) to OFC-2 (post-treatment). The maximum tolerated dose is defined as the highest cumulative dose ingested without dose-limiting allergic symptoms. Changes will be analyzed within and between study groups.
Incidence, Type and Severity of Adverse Events During Immunotherapy Compared with Control (WAO Grading)
Number, type, and severity of adverse events during immunotherapy compared with the control group, assessed based on symptom diaries and classified by severity according to the WAO scale.
Change in Skin Prick Test (SPT) Wheal Diameter for Peanut and Tree Nut Allergens from Baseline to Final Assessment
Measurement of change in wheal diameter (mm) for peanut and tree nut allergens as assessed by skin prick testing (SPT) between baseline (OFC-1) and final assessment (OFC-2). Wheal size will be recorded as the mean diameter and compared within and between study groups.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
