Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial

Elodie Michaud (1) , Bertrand Evrard (2, 3, 4) , Bruno Pereira (5) , Emmanuelle Rochette (6, 7, 8) , Lucie Bernard (9) , Paul-Olivier Rouzaire (4) , Nelly Gourdon-Dubois (6, 8) , Etienne Merlin (6, 7) , Jean-Luc Fauquert (10)

1 Unité d’allergologie de l’enfant
2 UNH - Unité de Nutrition Humaine
3 INSERM - Institut National de la Santé et de la Recherche Médicale
4 Département d’immunobiologie
5 DRCI - Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand]
6 CIC Clermont Ferrand
7 Pole pédiatrique, Service de pédiatrie générale et Multidisciplinaire
8 CHU Clermont-Ferrand
9 Département de Pharmacie
10 Pole pédiatrique, Unité d’allergologie de l’enfant

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.

Mots clés: Peanut allergy; Oral immunotherapy; Adolescent; Double blind placebo; controlled oral food challenge; food; anaphylaxis; children; allergy

Domaines: Alimentation et Nutrition

Elodie Michaud, Bertrand Evrard, Bruno Pereira, Emmanuelle Rochette, Lucie Bernard, et al.. Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial. Trials, 2015, 16, n.p. ⟨10.1186/s13063-015-0717-y⟩. ⟨hal-01219011⟩