title: A randomized trial of egg introduction from 4 months of age in infants at risk for egg allergy.
abstract: BACKGROUND
  Epidemiologic evidence suggests delayed introduction of egg might not protect against egg allergy in infants at risk of allergic disease.
  
  
  OBJECTIVE
  We sought to assess whether dietary introduction of egg between 4 and 6 months in infants at risk of allergy would reduce sensitization to egg.
  
  
  METHODS
  We conducted a randomized controlled trial in infants with at least 1 first-degree relative with allergic disease. Infants with a skin prick test (SPT) response to egg white (EW) of less than 2 mm were randomized at age 4 months to receive whole-egg powder or placebo (rice powder) until 8 months of age, with all other dietary egg excluded. Diets were liberalized at 8 months in both groups. The primary outcome was an EW SPT response of 3 mm or greater at age 12 months.
  
  
  RESULTS
  Three hundred nineteen infants were randomized: 165 to egg and 154 to placebo. Fourteen infants reacted to egg within 1 week of introduction (despite an EW SPT response <2 mm at entry) and were unsuitable for intervention. Two hundred fifty-four (83%) infants were assessed at 12 months of age. Loss to follow-up was similar between groups. Sensitization to EW at 12 months was 20% and 11% in infants randomized to placebo and egg, respectively (odds ratio, 0.46; 95% CI, 0.22-0.95; P = .03, χ2test). The absolute risk reduction was 9.8% (95% CI, 8.2% to 18.9%), with a number needed to treat of 11 (95% CI, 6-122). Levels of IgG4to egg proteins and IgG4/IgE ratios were higher in those randomized to egg (P < .0001 for each) at 12 months. There was no effect on the proportion of children with probable egg allergy (placebo, 13; egg, 8).
  
  
  CONCLUSIONS
  Introduction of whole-egg powder into the diets of high-risk infants reduced sensitization to EW and induced egg-specific IgG4levels. However, 8.5% of infants randomized to egg were not amenable to this primary prevention.
authors.affiliation: Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia; Department of Allergy and Immunology, Children's Hospital at Westmead, Sydney, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Wei-Liang Tan
authors.affiliation: Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia; Department of Allergy and Immunology, Children's Hospital at Westmead, Sydney, Australia.
authors.forename: Carolina
authors.initials: C
authors.lastname: Valerio
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Barnes
authors.affiliation: Section of Paediatrics (Allergy and Infectious Diseases) and MRC and Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Turner
authors.affiliation: Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia; Department of Allergy and Immunology, Children's Hospital at Westmead, Sydney, Australia.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Van Asperen
authors.affiliation: Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia; Department of Allergy and Immunology, Children's Hospital at Westmead, Sydney, Australia.
authors.forename: Alyson M
authors.initials: AM
authors.lastname: Kakakios
authors.affiliation: Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia; Department of Allergy and Immunology, Children's Hospital at Westmead, Sydney, Australia. Electronic address: dianne.campbell1@health.nsw.gov.au.
authors.forename: Dianne E
authors.initials: DE
authors.lastname: Campbell
mesh_terms: D004311:Double-Blind Method; D021181:Egg Hypersensitivity / Q000097:blood / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control*; D004527:Egg Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D004529:Egg White / Q000009:adverse effects; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D011322:Primary Prevention; D012882:Skin Tests
chemical_list: D004527:Egg Proteins; D007074:Immunoglobulin G; D007073:Immunoglobulin E
keywords: Primary prevention; egg allergy; tolerance