title: Infections in infants fed formula supplemented with bovine milk fat globule membranes.
abstract: OBJECTIVE
  Observational studies have shown that even in high-income countries formula-fed infants have a higher incidence of acute otitis media (AOM), and gastrointestinal and respiratory tract infections during the first year of life compared with breast-fed infants. We hypothesized that components of the milk fat globule membrane (MFGM) may be responsible for some of these differences and that supplementation with bovine MFGM would decrease the infectious morbidity in formula-fed infants.
  
  
  METHODS
  In a double-blind randomized controlled trial, 160 formula-fed infants received experimental formula (EF) supplemented with bovine MFGM (EF) or unsupplemented standard formula (SF) from <2 months until 6 months of age. A breast-fed reference group consisted of 80 infants. Disease symptoms, health care contacts, and medication were recorded by the parents until 12 months of age. Serum immunoglobulin G for 10 pneumococcal serotypes was analyzed at 6 months of age.
  
  
  RESULTS
  The cumulative incidence of AOM during the intervention was lower in the EF group than in the SF group (1% vs 9%, P = 0.034), and did not differ from the breast-fed reference group (0%, P = 1.0). The incidence (25% vs 43%, P = 0.021) and longitudinal prevalence (P = 0.012) of antipyretic use were significantly lower in the EF group than in the SF group. Serum immunoglobulin G concentrations against pneumococcal serotypes 1, 5, and 14 were lower in the EF group than in the SF group.
  
  
  CONCLUSIONS
  Supplementation of formula with bovine MFGM reduces the risk of AOM, decreases antipyretics use in formula-fed infants, and has immunomodulatory effects on humoral response against pneumococcus vaccine.
authors.affiliation: *Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden †Department of Vaccination and Immune Protection, National Institute for Health and Welfare, Helsinki, Finland ‡Department of Nutrition, University of California, Davis.
authors.forename: Niklas
authors.initials: N
authors.lastname: Timby
authors.forename: Olle
authors.initials: O
authors.lastname: Hernell
authors.forename: Outi
authors.initials: O
authors.lastname: Vaarala
authors.forename: Merit
authors.initials: M
authors.lastname: Melin
authors.forename: Bo
authors.initials: B
authors.lastname: Lönnerdal
authors.forename: Magnus
authors.initials: M
authors.lastname: Domellöf
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000627:therapeutic use; D058633:Antipyretics / Q000627:therapeutic use; D002417:Cattle; D002657:Child Development; D004311:Double-Blind Method; D057141:Food, Preserved / Q000032:analysis*; D005759:Gastroenteritis / Q000188:drug therapy / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D006017:Glycolipids / Q000627:therapeutic use*; D006023:Glycoproteins / Q000627:therapeutic use*; D006801:Humans; D056747:Immunomodulation; D015994:Incidence; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D007227:Infant Nutritional Physiological Phenomena; D066292:Lipid Droplets; D008137:Longitudinal Studies; D010033:Otitis Media / Q000188:drug therapy / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D011008:Pneumococcal Infections / Q000188:drug therapy / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D015995:Prevalence; D012141:Respiratory Tract Infections / Q000188:drug therapy / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D012306:Risk; D013548:Sweden / Q000453:epidemiology
chemical_list: D000890:Anti-Infective Agents; D058633:Antipyretics; D006017:Glycolipids; D006023:Glycoproteins; C110367:milk fat globule