Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy

Eur J Pediatr. 2014 Sep;173(9):1209-16. doi: 10.1007/s00431-014-2308-4. Epub 2014 Apr 12.

Abstract

Guidelines recommend the use of extensively hydrolyzed cow's milk protein-based formulas (eHF) in the treatment of infants with cow's milk protein allergy (CMPA). Extensively hydrolyzed rice protein infant formula (eRHF) has recently become available and could offer a valid alternative. A prospective trial was performed to evaluate the hypo-allergenicity and safety of a new eRHF in infants with a confirmed CMPA. Patients were fed the study formula for 6 months. Clinical tolerance of the eRHF was evaluated with a symptom-based score (SBS) and growth (weight and length) was monitored. Forty infants (mean age, 3.4 months; range, 1-6 months) with CMPA confirmed by a food challenge were enrolled. All infants tolerated the eRHF and the SBS significantly decreased as of the first month of intervention. Moreover, the eRHF allowed a catch-up to normal weight gain as of the first month as well as a normalization of the weight-for-age, weight-for length, and BMI z-scores within the 6-month study period.

Conclusion: In accordance with current guidelines, this eRHF was tolerated by more than 90 % of children with proven CMPA with a 95 % confidence interval. This eRHF is an adequate and safe alternative to cow milk-based eHF.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Belgium
  • Body Height
  • Body Weight
  • Cattle
  • Female
  • Follow-Up Studies
  • Growth
  • Guidelines as Topic
  • Humans
  • Immune Tolerance
  • Infant
  • Infant Formula* / administration & dosage
  • Infant Formula* / methods
  • Infant, Newborn
  • Male
  • Milk Hypersensitivity / diet therapy*
  • Milk Proteins / adverse effects*
  • Oryza*
  • Plant Proteins, Dietary / administration & dosage*
  • Prospective Studies
  • Protein Hydrolysates / administration & dosage*

Substances

  • Milk Proteins
  • Plant Proteins, Dietary
  • Protein Hydrolysates