title: Safety of a new extensively hydrolysed formula in children with cow's milk protein allergy: a double blind crossover study.
abstract: BACKGROUND
  Formulae for infants with cow's milk protein allergy (CMA) should be based on extensively hydrolysed protein. 'Extensively' however is not strictly defined. Differences in molecular weight and peptide chain length may affect its clinical outcome. We studied the safety of a new extensively hydrolysed casein based formula (Frisolac Allergycare: FAC) for children with IgE mediated CMA.
  
  
  METHODS
  Thirty children, aged 1.5 - 14.8 years old (median 4.9 years) with persistent CMA were enrolled in this double-blind reference product (Nutramigen: NUT) controlled crossover study. All had positive skin prick tests (SPT) and IgE mediated allergy, showing immediate reactions after ingestion of small amounts of milk. Twenty-five children also had positive radio allergen sorbent tests (RAST) to cow's milk. Formulae provided consisted of 80% elementary formula in combination with 20% reference or test product. Crossover periods lasted for two weeks. From both products molecular weight (MALDI-TOF method and HPLC) and peptide chain length distribution (adapted Edman degradation) were determined.
  
  
  RESULTS
  Maximum molecular weights of NUT and FAC are 2.1 and 2.56 kDa, respectively. The contribution of free amino acids and small peptides <0.5 kDa is 46% for FAC and 53% for NUT. About 50% of the protein fraction of both products consists of peptides longer than four amino acids. Three children did not complete the study. The other children all tolerated FAC very well; no adverse reactions were reported.
  
  
  CONCLUSIONS
  The new extensively hydrolysed casein-based formula (FAC) can safely be used in children with IgE mediated cow's milk allergy.
authors.affiliation: Department of Pediatrics, Wilhelmina Children's Hospital, Utrecht, The Netherlands. s.terheggen@wkz.azu.nl
authors.forename: Suzanne W J
authors.initials: SW
authors.lastname: Terheggen-Lagro
authors.forename: Ilse M S L
authors.initials: IM
authors.lastname: Khouw
authors.forename: Anne
authors.initials: A
authors.lastname: Schaafsma
authors.forename: Erik A K
authors.initials: EA
authors.lastname: Wauters
mesh_terms: D000293:Adolescent; D000818:Animals; D002364:Caseins / Q000737:chemistry; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D008297:Male; D016269:Milk Hypersensitivity / Q000276:immunology / Q000517:prevention & control*; D008894:Milk Proteins / Q000737:chemistry; D015394:Molecular Structure; D008970:Molecular Weight; D011492:Protein Hydrolysates / Q000737:chemistry
chemical_list: D002364:Caseins; D008894:Milk Proteins; D011492:Protein Hydrolysates; D007073:Immunoglobulin E