title: Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial.
abstract: BACKGROUND
  Evidence suggests that human milk oligosaccharides (HMOs) provide multiple benefits to infants, including prebiotic effects, gut maturation, antimicrobial activities, and immune modulation. Clinical intervention studies with HMOs are required to confirm these benefits in infants.
  
  
  OBJECTIVE
  Our objective was to investigate the effects of feeding formulas supplemented with the HMO 2'-fucosyllactose (2'-FL) on biomarkers of immune function in healthy term infants.
  
  
  METHODS
  We performed a substudy nested within a randomized, double-blind, controlled growth and tolerance study in healthy singleton infants (birth weight ≥2490 g) who were enrolled by 5 d of life and exclusively formula-fed (n = 317) or breastfed (n = 107) from enrollment to 4 mo of age. Formula-fed infants were randomly assigned to receive 1 of 3 formulas, all containing 2.4 g total oligosaccharides/L [control: galacto-oligosaccharides (GOS) only; experimental formulas: GOS + 0.2 or 1.0 g 2'-FL/L], and compared with a breastfed reference group. For this substudy, blood samples were drawn from infants at 6 wk of age (n = 31-42/group). Peripheral blood mononuclear cells (PBMCs) were isolated for cellular phenotyping and stimulated ex vivo with phytohemagglutinin for proliferation and cell cycle progression or respiratory syncytial virus (RSV). Cytokine concentrations were measured in plasma and in ex vivo-stimulated culture supernatants.
  
  
  RESULTS
  Breastfed infants and infants fed either of the experimental formulas with 2'-FL were not different but had 29-83% lower concentrations of plasma inflammatory cytokines than did infants fed the control formula [interleukin (IL) receptor antagonist (IL-1ra), IL-1α, IL-1β, IL-6, and tumor necrosis factor α (TNF-α)] (P ≤ 0.05). In ex vivo RSV-stimulated PBMC cultures, breastfed infants were not different than either of the groups fed formula with 2'-FL, but they had lower concentrations of TNF-α (31%) and interferon γ (IFN-γ 54%) (P ≤ 0.05) and tended to have lower IL-1ra (25%) and IL-6 (38%) (unadjusted P ≤ 0.05) and IL-1β (30%) (unadjusted P = 0.06) than did infants fed the control formula.
  
  
  CONCLUSIONS
  Our data indicate that infants fed formula supplemented with 2'-FL exhibit lower plasma and ex vivo inflammatory cytokine profiles, similar to those of a breastfed reference group. This trial was registered at clinicaltrials.gov as NCT01808105.
authors: Research and Development and.
authors: Karen C
authors: KC
authors: Goehring
authors: Regulatory Affairs, Abbott Nutrition, Columbus, OH; and.
authors: Barbara J
authors: BJ
authors: Marriage
authors: Research and Development and.
authors: Jeffery S
authors: JS
authors: Oliver
authors: Lovelace Respiratory Research Institute, Albuquerque, NM.
authors: Julie A
authors: JA
authors: Wilder
authors: Lovelace Respiratory Research Institute, Albuquerque, NM.
authors: Edward G
authors: EG
authors: Barrett
authors: Research and Development and rachael.buck@abbott.com.
authors: Rachael H
authors: RH
authors: Buck
mesh_terms: D001942:Breast Feeding; D049109:Cell Proliferation; D016207:Cytokines / Q000097:blood* / Q000378:metabolism; D004311:Double-Blind Method; D005786:Gene Expression Regulation; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D007249:Inflammation / Q000097:blood / Q000378:metabolism; D007963:Leukocytes, Mononuclear / Q000378:metabolism; D012136:Respiratory Syncytial Viruses / Q000302:isolation & purification; D014312:Trisaccharides / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology*; D019562:Viral Load
chemical_list: D016207:Cytokines; D014312:Trisaccharides; C031420:2'-fucosyllactose
keywords: 2'-fucosyllactose; breastfed infants; galacto-oligosaccharides; human milk oligosaccharides; infant formula; inflammatory cytokines