Mimi L K Tang1, Anne-Louise Ponsonby2, Francesca Orsini3, Dean Tey4, Marnie Robinson4, Ee Lyn Su4, Paul Licciardi5, Wesley Burks6, Susan Donath7. 1. Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Australia; Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia. Electronic address: mimi.tang@rch.org.au. 2. Environmental and Genetic Epidemiology, Murdoch Childrens Research Institute, Melbourne, Australia. 3. Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Australia. 4. Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Australia; Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia. 5. Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia. 6. Department of Pediatrics, University of North Carolina, Chapel Hill, NC. 7. Department of Paediatrics, University of Melbourne, Melbourne, Australia; Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Australia.
Abstract
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.
RCT Entities:
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 peanutallergy. 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 peanutallergy. 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.
Authors: John F Ryan; Rachel Hovde; Jacob Glanville; Shu-Chen Lyu; Xuhuai Ji; Sheena Gupta; Robert J Tibshirani; David C Jay; Scott D Boyd; R Sharon Chinthrajah; Mark M Davis; Stephen J Galli; Holden T Maecker; Kari C Nadeau Journal: Proc Natl Acad Sci U S A Date: 2016-01-25 Impact factor: 11.205
Authors: Julie Wang; Stacie M Jones; Jacqueline A Pongracic; Ying Song; Nan Yang; Scott H Sicherer; Melanie M Makhija; Rachel G Robison; Erin Moshier; James Godbold; Hugh A Sampson; Xiu-Min Li Journal: J Allergy Clin Immunol Date: 2015-06-01 Impact factor: 10.793
Authors: Elissa M Abrams; Stephanie C Erdle; Scott B Cameron; Lianne Soller; Edmond S Chan Journal: Curr Allergy Asthma Rep Date: 2021-04-30 Impact factor: 4.806
Authors: Brian P Vickery; Jelena P Berglund; Caitlin M Burk; Jason P Fine; Edwin H Kim; Jung In Kim; Corinne A Keet; Michael Kulis; Kelly G Orgel; Rishu Guo; Pamela H Steele; Yamini V Virkud; Ping Ye; Benjamin L Wright; Robert A Wood; A Wesley Burks Journal: J Allergy Clin Immunol Date: 2016-08-10 Impact factor: 10.793