title: Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula.
abstract: In case of cow's milk allergy (CMA), pediatric guidelines recommend for children the use of extensively hydrolyzed formulas (eHFs) as elimination diet. According to the American Academy of Pediatrics, the hypoallergenicity of each specific eHF should be tested in subjects with CMA.
  
  
  
  A prospective, multicenter trial was performed to assess the tolerance/hypoallergenicity of a thickened casein-based eHF (eHCF, Allernova AR®, United Pharmaceuticals, France) in infants aged <12 months with CMA proven by a double-blind placebo-controlled food challenge. Its efficacy, measured through allergy symptoms monitoring and Cow's Milk-related Symptom Score (CoMiSS) calculation, and safety were evaluated during a 4-month feeding period. Growth z-scores were computed based on WHO anthropometric data.
  
  
  
  Thirty infants (mean age: 4.8 ± 3.0 months) with CMA proven by a DBPCFC tolerated the eHCF during the 4-month study. The CoMiSS, crying and regurgitation scores significantly decreased by 4.2 ± 4.0, 0.9 ±1.2 and 0.7 ± 1.1 respectively, after 14 days of feeding (p < 0.001). The Scoring Atopic Dermatitis index, of 33.2 ± 14.8 at inclusion in 9 patients, significantly decreased by 15.5 ± 6.7 and 21.1 ± 11.2, after 14 and 45 days of feeding, respectively (p < 0.001). The percentage of infants having normal stool consistency (soft or formed stools) significantly improved from 66.7 % (20/30) at inclusion to 90.0 % (27/30) after 14 days of feeding (p = 0.020). The growth z-scores, negative at study inclusion, significantly improved over the 4-month study. No adverse event was related to the eHCF.
  
  
  
  The thickened eHCF was tolerated by more than 90 % of included allergic infants with 95 % confidence interval and can therefore be considered as hypoallergenic in accordance with current guidelines. The improvement of growth indices and absence of related adverse events confirmed its safety. Results of this trial back the use of the tested thickened eHCF as an efficient and safe alternative in children with CMA.
  
  
  
  ClinicalTrials.gov, number NCT02351531 , registered on 27 January 2015.
authors.affiliation: Pediatric Gastroenterology, Hepatology and Nutrition Department, Necker Children's Hospital, 149, rue de Sèvres, 75015, Paris, France. christophe.dupont@nck.aphp.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Dupont
authors.affiliation: Department of Pediatrics, Regional Hospital, Namur, Belgium.
authors.forename: Elena
authors.initials: E
authors.lastname: Bradatan
authors.affiliation: Pediatric Gastroenterology, Hepatology and Nutrition Department, Necker Children's Hospital, 149, rue de Sèvres, 75015, Paris, France.
authors.forename: Pascale
authors.initials: P
authors.lastname: Soulaines
authors.affiliation: Department of Translational Medical Science and European Laboratory for the Investigation of Food Induced Diseases and CEINGE Advanced Biotechnologies, University of Naples "Federico II", Naples, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Nocerino
authors.affiliation: Department of Translational Medical Science and European Laboratory for the Investigation of Food Induced Diseases and CEINGE Advanced Biotechnologies, University of Naples "Federico II", Naples, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Berni-Canani
mesh_terms: D001827:Body Height; D002364:Caseins / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000009:adverse effects; D008297:Male; D016269:Milk Hypersensitivity / Q000175:diagnosis / Q000178:diet therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D015430:Weight Gain
chemical_list: D002364:Caseins
keywords: Cow’s Milk-related Symptom Score (CoMiSS); Cow’s milk allergy; Hypoallergenic extensively hydrolyzed casein-based formula; Infant growth; Scoring Atopic Dermatitis (SCORAD)