title: Randomized placebo-controlled trial of hen's egg consumption for primary prevention in infants.
abstract: BACKGROUND
  Hen's egg is the most common cause of food allergy in early childhood.
  
  
  OBJECTIVE
  We investigated the efficacy and safety of early hen's egg introduction at age 4 to 6 months to prevent hen's egg allergy in the general population.
  
  
  METHODS
  This randomized, placebo-controlled trial included 4- to 6-month-old infants who were not sensitized against hen's egg, as determined based on specific serum antibodies (IgE). These infants were randomized to receive either verum (egg white powder) or placebo (rice powder) added to the first weaning food 3 times a week under a concurrent egg-free diet from age 4 to 6 until 12 months. The primary outcome was sensitization to hen's egg (increased specific serum IgE levels) by age 12 months. Hen's egg allergy (secondary outcome) was confirmed by double-blind, placebo-controlled food challenges.
  
  
  RESULTS
  Among 406 screened infants, 23 (5.7%) had hen's egg-specific IgE before randomization. Seventeen of 23 underwent subsequent double-blind, placebo-controlled food challenges, and 16 were confirmed as allergic, including 11 with anaphylactic reactions. Of the 383 nonsensitized infants (56.7% male), 184 were randomized to verum and 199 to placebo. At 12 months of age, 5.6% of the children in the verum group were hen's egg sensitized versus 2.6% in the placebo group (primary outcome; relative risk, 2.20; 95% CI, 0.68-7.14; P = .24), and 2.1% were confirmed to have hen's egg allergy versus 0.6% in the placebo group (relative risk, 3.30; 95% CI, 0.35-31.32; P = .35).
  
  
  CONCLUSIONS
  We found no evidence that consumption of hen's egg starting at 4 to 6 months of age prevents hen's egg sensitization or allergy. In contrast, it might result in frequent allergic reactions in the community considering that many 4- to 6-month-old infants were already allergic to hen's egg.
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Johanna
authors: J
authors: Bellach
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Veronika
authors: V
authors: Schwarz
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Birgit
authors: B
authors: Ahrens
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Valérie
authors: V
authors: Trendelenburg
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Özlem
authors: Ö
authors: Aksünger
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Birgit
authors: B
authors: Kalb
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Bodo
authors: B
authors: Niggemann
authors: Institute for Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin-Berlin, Berlin, Germany.
authors: Thomas
authors: T
authors: Keil
authors: Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany; Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: kirsten.beyer@charite.de.
authors: Kirsten
authors: K
authors: Beyer
mesh_terms: D000707:Anaphylaxis / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D000818:Animals; D002645:Chickens; 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; D007223:Infant; D008297:Male; D011322:Primary Prevention
chemical_list: D004527:Egg Proteins; D007073:Immunoglobulin E
keywords: Food allergy; allergy prevention; atopic eczema; complementary feeding; hen's egg allergy; oral tolerance; randomized controlled trial