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

Abstract

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).

Figures

Figure 1

Study design. Children aged 12 to 18 years with peanut allergy proven in a first double-blind placebo-controlled oral food challenge (DBPCOFC) will enter a double-blind placebo-controlled induction phase through a first 2:1 randomization (R1). After a successful build-up phase, the maintenance phase duration will be determined by a second 1:1 randomization (R2). Double arrow: DBPCOFC. (dotted area: 24 weeks normal dietary; shaded area : 6 weeks wash-out).