title: Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial.
abstract: OBJECTIVE
  To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG).
  
  
  METHODS
  A prospective, randomised, double-blind, placebo-controlled crossover trial.
  
  
  METHODS
  Two study sites in Italy and The Netherlands.
  
  
  METHODS
  Children with documented cow's milk allergy were eligible for inclusion in this trial.
  
  
  METHODS
  After a 7-day period of strict avoidance of cow's milk protein and other suspected food allergens, participants were tested with an EH casein formula with demonstrated hypoallergenicity (control, EHF) and a formula of the same composition with LGG added at 10(8) colony-forming units per gram powder (EHF-LGG) in randomised order in a double-blind placebo-controlled food challenge (DBPCFC). After absence of adverse reactions in the DBPCFC, an open challenge was performed with EHF-LGG, followed by a 7-day home feeding period with the same formula.
  
  
  METHODS
  Clinical assessment of any adverse reactions to ingestion of study formulae during the DBPCFC.
  
  
  RESULTS
  For all participants with confirmed cow's milk allergy (n=31), the DBPCFC and open challenge were classified as negative.
  
  
  CONCLUSIONS
  The EH casein formula supplemented with LGG is hypoallergenic and can be recommended for infants and children allergic to cow's milk who require an alternative to formulae containing intact cow's milk protein.
  
  
  BACKGROUND
  http://ClinicalTrials.gov Identifier: NCT01181297.
authors.affiliation: The Food Allergy Referral Centre, Department of Pediatrics, Veneto Region, Università degli Studi di Padova, Padova, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Muraro
authors.forename: Maarten O
authors.initials: MO
authors.lastname: Hoekstra
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Meijer
authors.forename: Carlos
authors.initials: C
authors.lastname: Lifschitz
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Wampler
authors.forename: Cheryl
authors.initials: C
authors.lastname: Harris
authors.forename: Deolinda M F
authors.initials: DM
authors.lastname: Scalabrin