Administration of a probiotic with peanut oral immunotherapy: A randomized trial

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:135

Article

Tang, Mimi L. K.^1,2,3  Ponsonby, Anne-Louise⁴  Orsini, Francesca⁵  Tey, Dean^1,3  Robinson, Marnie^1,3  Su, Ee Lyn^1,3  Licciardi, Paul³  Burks, Wesley⁶  Donath, Susan^2,5 

[1] Royal Childrens Hosp, Dept Allergy & Immunol, Melbourne, Vic, Australia

[2] Univ Melbourne, Dept Paediat, Melbourne, Vic, Australia

[3] Murdoch Childrens Res Inst, Allergy & Immune Disorders, Melbourne, Vic, Australia

[4] Murdoch Childrens Res Inst, Environm & Genet Epidemiol, Melbourne, Vic, Australia

[5] Murdoch Childrens Res Inst, Clin Epidemiol & Biostat Unit, Melbourne, Vic, Australia

[6] Univ N Carolina, Dept Pediat, Chapel Hill, NC USA

关键词: Peanut allergy;    oral immunotherapy;    probiotic;    immune-modifying adjuvant;    tolerance;    sustained unresponsiveness;    desensitization;    peanut-specific IgE;    peanut-specific IgG(4);   

DOI  :  10.1016/j.jaci.2014.11.034

来源: Elsevier

【 摘 要 】

Background: Coadministration of a bacterial adjuvant with oral immunotherapy (OIT) has been suggested as a potential treatment for food allergy. Objective: To evaluate a combined therapy comprising a probiotic together with peanut OIT. Methods: We performed a double-blind, placebo-controlled randomized trial of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 and peanut OIT (probiotic and peanut oral immunotherapy [PPOIT]) in children (1-10 years) with peanut allergy. The primary outcome was induction of sustained unresponsiveness 2 to 5 weeks after discontinuation of treatment (referred to as possible sustained unresponsiveness). Secondary outcomes were desensitization, peanut skin prick test, and specific IgE and specific IgG4 measurements. Results: Sixty-two children were randomized and stratified by age (<= 5 and > 5 years) and peanut skin test wheal size (<= 10 and > 10 mm); 56 reached the trial's end. Baseline demographics were similar across groups. Possible sustained unresponsiveness was achieved in 82.1% receiving PPOIT and 3.6% receiving placebo (P<. 001). Nine children need to be treated for 7 to achieve sustained unresponsiveness (number needed to treat, 1.27; 95% CI, 1.06-1.59). Of the subjects, 89.7% receiving PPOIT and 7.1% receiving placebo were desensitized (P <.001). PPOIT was associated with reduced peanut skin prick test responses and peanut-specific IgE levels and increased peanut-specific IgG4 levels (all P <.001). PPOIT-treated participants reported a greater number of adverse events, mostly with maintenance home dosing. Conclusion: This is the first randomized placebo-controlled trial evaluating the novel coadministration of a probiotic and peanut OIT and assessing sustained unresponsiveness in children with peanut allergy. PPOIT was effective in inducing possible sustained unresponsiveness and immune changes that suggest modulation of the peanut-specific immune response. Further work is required to confirm sustained unresponsiveness after a longer period of secondary peanut elimination and to clarify the relative contributions of probiotics versus OIT.

【 授权许可】

Free