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

• Published in: Journal of allergy and clinical immunology Vol. 135; no. 3; pp. 737 - 744.e8
• Main Authors: Tang, Mimi L.K., Ponsonby, Anne-Louise, Orsini, Francesca, Tey, Dean, Robinson, Marnie, Su, Ee Lyn, Licciardi, Paul, Burks, Wesley, Donath, Susan
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2015; Elsevier Limited
• Subjects: Abdomen; Administration, Oral; Allergens - administration & dosage; Allergies; Allergy and Immunology; Arachis - chemistry; Arachis - immunology; Arachis hypogaea; Child; Child, Preschool; Clinical trials; desensitization; Desensitization, Immunologic - methods; Double-Blind Method; Female; Food; Food allergies; Humans; immune-modifying adjuvant; Immunoglobulin E - blood; Immunoglobulin G - blood; Immunotherapy; Infant; Lactobacillus rhamnosus; Male; oral immunotherapy; Pain; Peanut allergy; Peanut Hypersensitivity - immunology; Peanut Hypersensitivity - physiopathology; Peanut Hypersensitivity - therapy; peanut-specific IgE; peanut-specific IgG4; Peanuts; probiotic; Probiotics; Probiotics - administration & dosage; Proteins; Skin Tests; Studies; sustained unresponsiveness; tolerance; Treatment Outcome; RR; sIgE; FDA; RCT; sIgG4; oral immunotherapy; peanut-specific IgG4; NNT; SPT; tolerance; peanut-specific IgE; OR; AE; IQR; immune-modifying adjuvant; NIAID; desensitization; probiotic; Peanut allergy; PPOIT; RCH; SAE; sustained unresponsiveness; OIT; DBPCFC; Risk ratio; Number needed to treat; Specific IgG 4; Serious adverse event; peanut-specific IgG 4; US Food and Drug Administration; Double-blind, placebo-controlled food challenge; Specific IgE; Adverse event; Skin prick test; Probiotic and peanut oral immunotherapy; Royal Children's Hospital; Randomized controlled trial; National Institute of Allergy and Infectious Diseases; Interquartile range; Odds ratio; sIgG 4; peanut-specific IgG
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2014.11.034

Coadministration of a bacterial adjuvant with oral immunotherapy (OIT) has been suggested as a potential treatment for food allergy. To evaluate a combined therapy comprising a probiotic together with peanut OIT. 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. 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. 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.