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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrial.gov: NCT02046083 (23 January 2014).
CHU 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.
Elodie
E
Michaud
CHU Clermont-Ferrand, Département d'immunobiologie, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. bevrard@chu-clermontferrand.fr.|INSERM, UMR1019, F-63003, Clermont-Ferrand, France. bevrard@chu-clermontferrand.fr.
Bertrand
B
Evrard
CHU Clermont-Ferrand, Unité de Biostatistiques, Direction de la Recherche Clinique (DRCI), 58 rue Montalembert, F-63003, Clermont-Ferrand, France. bpereira@chu-clermontferrand.fr.
Bruno
B
Pereira
INSERM, CIC 1405, CHU, F-63003, Clermont-Ferrand, France. e_rochette@chu-clermontferrand.fr.|CHU Clermont-Ferrand, Pole pédiatrique, Service de pédiatrie générale et Multidisciplinaire, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. e_rochette@chu-clermontferrand.fr.
Emmanuelle
E
Rochette
CHU Clermont-Ferrand, Département de Pharmacie, 58 rue Montalembert, F-63003, Clermont-Ferrand, France. l_bernard@chu-clermontferrand.fr.
Lise
L
Bernard
CHU Clermont-Ferrand, Département d'immunobiologie, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. porouzaire@chu-clermontferrand.fr.
Paul-Olivier
PO
Rouzaire
INSERM, CIC 1405, CHU, F-63003, Clermont-Ferrand, France. ngourdondubois@chu-clermontferrand.fr.|CHU Clermont-Ferrand, Pole pédiatrique, Service de pédiatrie générale et Multidisciplinaire, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. ngourdondubois@chu-clermontferrand.fr.
Nelly
N
Gourdon-Dubois
INSERM, CIC 1405, CHU, F-63003, Clermont-Ferrand, France. e_merlin@chu-clermontferrand.fr.|CHU Clermont-Ferrand, Pole pédiatrique, Service de pédiatrie générale et Multidisciplinaire, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. e_merlin@chu-clermontferrand.fr.
Etienne
E
Merlin
CHU Clermont-Ferrand, Pole pédiatrique, Unité d'allergologie de l'enfant, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France. jlfauquert@chu-clermontferrand.fr.
Jean-Luc
JL
Fauquert
D000284:Administration, Oral; D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage* / Q000276:immunology; D010367:Arachis / Q000009:adverse effects / Q000276:immunology; D002648:Child; D002985:Clinical Protocols; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D009754:Nuts / Q000009:adverse effects / Q000276:immunology; D021183:Peanut Hypersensitivity / Q000175:diagnosis / Q000276:immunology / Q000628:therapy*; D012107:Research Design; D012882:Skin Tests; D013997:Time Factors; D016896:Treatment Outcome
D000485:Allergens