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Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial
Elodie Michaud1, Bertrand Evrard2,3, Bruno Pereira4
1CHU Clermont-Ferrand, Pole pédiatrique, Unité d'allergologie de l'enfant, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. emichaud@chu-clermontferrand.fr.
Insights
Peanut oral immunotherapy shows promise for adolescents with peanut allergy, increasing tolerance and reducing reactions to accidental intake. This study evaluates its efficacy and safety in this at-risk age group.
Area of Science:
- Allergy and Immunology
- Pediatric Gastroenterology
- Clinical Trials
Background:
- Peanut allergy is a prevalent and growing health concern.
- Current management relies on strict allergen avoidance.
- Oral immunotherapy (OIT) offers a potential therapeutic strategy, with emerging positive outcomes in children.
Purpose of the Study:
- To assess the efficacy and safety of peanut OIT in individuals aged 12-18 years with confirmed peanut allergy.
- To determine if OIT can increase tolerance to peanut, thereby reducing the risk of severe reactions.
- To improve the quality of life for adolescent peanut allergy patients.
Main Methods:
- A randomized, double-blind, placebo-controlled, multicenter trial involving 12- to 18-year-olds.
- Gradual up-dosing of peanut or placebo from 10 mg to 2 g over 24 weeks.
- A subsequent unblinded maintenance phase and ongoing monitoring of adverse events.
Main Results:
- The primary endpoint is the proportion of patients achieving tolerance (negative double-blind, placebo-controlled food challenge at 2g peanut) post-build-up.
- Secondary endpoints include sustained desensitization, adverse event rates, and immunological markers.
- Immunological assays will track changes throughout the study.
Conclusions:
- This study represents a novel evaluation of OIT specifically in the adolescent population.
- It aims to provide evidence for reducing severe reactions from accidental peanut exposure.
- The findings could significantly impact treatment guidelines and patient quality of life.
Background:
Peanut allergy is an increasingly common health problem. Current treatment guidelines are based on strict avoidance. However, in the last few years, oral immunotherapy protocols have shown promising results yielding increased tolerance to peanut in allergic children. Adolescence is particularly at risk.
Methods/Design:
We have designed a randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of peanut oral escalating immunotherapy in a 12- to 18-year-old population with proved allergy to peanut. Patients are selected when the threshold of peanut intake is over 100 mg and 2 cumulated g on the first double-blind, placebo-controlled oral food challenge (DBPCOFC). During the build-up placebo-controlled blinded phase, doses containing peanut or placebo will be administered by gradual up-dosing from 10 mg to 2 g with 2-weekly increments. After this first randomized phase, the desensitized participants will continue to intake native peanut in an unblinded process during 13 or 37 weeks following a second randomization. Adverse events are picked up and managed throughout the entire protocol. The main endpoint is the percentage of patients with negative DBPCOFC at the threshold of 2 g of cumulative peanut at the end of the build-up phase of 24 weeks. Secondary endpoints include: (1) desensitization 6 weeks and 6 months after the end of the maintenance phase; (2) adverse effects during the build-up phase; (3) immunological profile confirming peanut desensitization. Immunologic assays will be carried out at every DBPCOFC and at the middle of the build-up phase to evaluate the peanut immunologic profile modifications.
Discussion:
This double-blind, placebo-controlled study will be, to our knowledge, the first evaluation of a peanut oral immunotherapy protocol in teenagers in the purpose to reduce severe reactions after unexpected intake and to improve quality of life.
Trial Registration:
ClinicalTrial.gov: NCT02046083 (23 January 2014).
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