title: Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy: a randomized controlled clinical trial.
abstract: BACKGROUND
  Amino acid-based formulas (Aaf) are increasingly used in children with cow's milk allergy (CMA). To be labeled hypoallergenic these formulas must demonstrate in clinical studies that they don't provoke reactions in 90% of subjects with confirmed CMA with 95% confidence when given in prospective randomized, double-blind, placebo-controlled challenge (DBPCFC) trials. The majority of available safety data on Aaf derived from patients with IgE-mediated CMA. Considering substantial differences in the immunologic mechanism and clinical presentation of non-IgE-mediated CMA it's important to investigate the hypoallergenicity of these formulas also in these patients. We prospectively assessed the tolerance to a new commercially available Aaf in children affected by IgE- or non-IgE-mediated CMA.
  
  
  METHODS
  Consecutive patients affected by IgE- or non-IgE-mediated CMA, aged ≤ 4 years, were enrolled. DBPCFC was carried out with increasing doses of the new Aaf (Sineall, Humana, Milan, Italy), using validated Aaf as placebo. Faecal concentrations of calprotectin (FC) and eosinophilic cationic protein (ECP) were monitored.
  
  
  RESULTS
  Sixty patients (44 male, 73.3%, median age 37, 95%CI 34.5-39.6 months, IgE-mediated CMA 29, 48.3%) were enrolled. At the diagnosis clinical symptoms were gastrointestinal (46.6%), cutaneous (36.6%), respiratory (23.3%), and systemic (10.0%). After DBPCFC with the new Aaf, no patient presented early or delayed clinical reactions. Faecal concentration of calprotectin and of ECP remained stable after the exposure to the new Aaf.
  
  
  CONCLUSIONS
  The new Aaf is well tolerated in children with IgE- or non-IgE-mediated CMA, and it could be used as a safe dietotherapy regimen for children with this condition.
  
  
  BACKGROUND
  The trial was registered in the ClinicalTrials.gov Protocol Registration System (ID number: NCT01622426).
authors: Department of Paediatrics, European Laboratory for the Investigation of Food Induced Diseases (ELFID), University of Naples Federico II, Via S, Pansini, 5-80131, Naples, Italy. berni@unina.it
authors: Roberto
authors: R
authors: Berni Canani
authors: Rita
authors: R
authors: Nocerino
authors: Ludovica
authors: L
authors: Leone
authors: Margherita
authors: M
authors: Di Costanzo
authors: Gianluca
authors: G
authors: Terrin
authors: Annalisa
authors: A
authors: Passariello
authors: Linda
authors: L
authors: Cosenza
authors: Riccardo
authors: R
authors: Troncone
mesh_terms: D000596:Amino Acids / Q000009:adverse effects; D015415:Biomarkers / Q000378:metabolism; D002675:Child, Preschool; D004311:Double-Blind Method; D047150:Eosinophil Cationic Protein / Q000378:metabolism; D005260:Female; D005526:Food, Formulated / Q000009:adverse effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007413:Intestinal Mucosa / Q000378:metabolism; D039841:Leukocyte L1 Antigen Complex / Q000378:metabolism; D008297:Male; D016269:Milk Hypersensitivity / Q000175:diagnosis / Q000178:diet therapy* / Q000276:immunology / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D000596:Amino Acids; D015415:Biomarkers; D039841:Leukocyte L1 Antigen Complex; D007073:Immunoglobulin E; D047150:Eosinophil Cationic Protein