title: Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants.
abstract: BACKGROUND
  Children with cow's milk allergy (CMA) are at risk for inadequate nutritional intake and growth. Dietary management of CMA, therefore, requires diets that are not only hypoallergenic but also support adequate growth in this population. This study assessed growth of CMA infants when using a new amino acid-based formula (AAF) with prebiotics and probiotics (synbiotics) and evaluated its safety in the intended population.
  
  
  METHODS
  In a prospective, randomized, double-blind controlled study, full-term infants with diagnosed CMA received either an AAF (control; n = 56) or AAF with synbiotics (oligofructose, long-chain inulin, acidic oligosaccharides, Bifidobacterium breve M-16V) (test; n = 54) for 16 wk. Primary outcome was growth, measured as weight, length and head circumference. Secondary outcomes included allergic symptoms and stool characteristics.
  
  
  RESULTS
  Average age (±SD) of infants at inclusion was 4.5 ± 2.4 months. Both formulas equally supported growth according to WHO 2006 growth charts and resulted in similar increases of weight, length and head circumference. At week 16, differences (90% CI) in Z-scores (test-control) were as follows: weight 0.147 (-0.10; 0.39, p = 0.32), length -0.299 (-0.69; 0.09, p = 0.21) and head circumference 0.152 (-0.15; 0.45, p = 0.40). Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups. Both formulas were well tolerated and reduced allergic symptoms; the number of adverse events was not different between the groups.
  
  
  CONCLUSIONS
  This is the first study that shows that an AAF with a specific synbiotic blend, suitable for CMA infants, supports normal growth and growth similar to the AAF without synbiotics. This clinical trial is registered as NCT00664768.
authors.affiliation: University of North Carolina, Chapel Hill, NC, USA.
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
authors.affiliation: Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.
authors.forename: Lucien F
authors.initials: LF
authors.lastname: Harthoorn
authors.affiliation: Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.|Nutricia Advanced Medical Nutrition, Liverpool, UK.
authors.forename: Marleen T J
authors.initials: MT
authors.lastname: Van Ampting
authors.affiliation: Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.
authors.forename: Manon M
authors.initials: MM
authors.lastname: Oude Nijhuis
authors.affiliation: Nutricia Advanced Medical Nutrition, Liverpool, UK.
authors.forename: Jane E
authors.initials: JE
authors.lastname: Langford
authors.affiliation: Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.|Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.
authors.forename: Harm
authors.initials: H
authors.lastname: Wopereis
authors.affiliation: Visions Clinical Research, Tucson, AZ, USA.
authors.forename: Steven B
authors.initials: SB
authors.lastname: Goldberg
authors.affiliation: Children's Hospital Los Angeles/University of Southern California, Los Angeles, CA, USA.
authors.forename: Peck Y
authors.initials: PY
authors.lastname: Ong
authors.affiliation: Meridian Clinical Research, Omaha, NE, USA.
authors.forename: Brandon J
authors.initials: BJ
authors.lastname: Essink
authors.affiliation: Asheboro Research Associates, Asheboro, NC, USA.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Scott
authors.affiliation: Children's Investigational Research Program, LLC (CHIRP), Bentonville, AR, USA.
authors.forename: Bryan M
authors.initials: BM
authors.lastname: Harvey
mesh_terms: D000596:Amino Acids / Q000008:administration & dosage; D002657:Child Development; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage* / Q000706:statistics & numerical data; D007228:Infant Nutrition Disorders / Q000517:prevention & control*; D007231:Infant, Newborn; D008297:Male; D016269:Milk Hypersensitivity / Q000276:immunology*; D011446:Prospective Studies; D058616:Synbiotics / Q000008:administration & dosage* / Q000706:statistics & numerical data
chemical_list: D000596:Amino Acids
keywords: amino acid-based formula; cow's milk allergy; growth; infant; prebiotics; probiotics; randomized double-blind controlled trial; safety