title: Administration of a probiotic with peanut oral immunotherapy: A randomized trial.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Mimi L K
authors.initials: ML
authors.lastname: Tang
authors.affiliation: Environmental and Genetic Epidemiology, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Anne-Louise
authors.initials: AL
authors.lastname: Ponsonby
authors.affiliation: Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Francesca
authors.initials: F
authors.lastname: Orsini
authors.affiliation: Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Australia; Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Dean
authors.initials: D
authors.lastname: Tey
authors.affiliation: Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Australia; Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Marnie
authors.initials: M
authors.lastname: Robinson
authors.affiliation: Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Australia; Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Ee Lyn
authors.initials: EL
authors.lastname: Su
authors.affiliation: Allergy and Immune Disorders, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Licciardi
authors.affiliation: Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
authors.forename: Wesley
authors.initials: W
authors.lastname: Burks
authors.affiliation: Department of Paediatrics, University of Melbourne, Melbourne, Australia; Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Donath
mesh_terms: D000284:Administration, Oral; D000485:Allergens / Q000008:administration & dosage*; D010367:Arachis / Q000737:chemistry / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood*; D007074:Immunoglobulin G / Q000097:blood*; D007223:Infant; D008297:Male; D021183:Peanut Hypersensitivity / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D019936:Probiotics / Q000008:administration & dosage*; D012882:Skin Tests; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D007074:Immunoglobulin G; D007073:Immunoglobulin E
keywords: Peanut allergy; desensitization; immune-modifying adjuvant; oral immunotherapy; peanut-specific IgE; peanut-specific IgG(4); probiotic; sustained unresponsiveness; tolerance