Efficacy and safety of hydrolyzed cow milk and amino acid-derived formulas in infants with cow milk allergy

J Pediatr. 1995 Oct;127(4):550-7. doi: 10.1016/s0022-3476(95)70111-7.


Objective: To determine the antigenicity, nutritional adequacy, and growth-promoting efficacy of protein hydrolysate or amino acid-derived formulas in infants with cow milk allergy.

Study design: Several protein hydrolysate or amino acid-derived formulas were graded for beta-lactoglobulin content and skin reactivity in 74 atopic children with cow milk allergy proved by a double-blind, placebo-controlled challenge. A randomized, prospective follow-up study of 9 months included 22 infants with a mean age of 6 months (95% confidence interval, 4 to 7), who were fed an extensively hydrolyzed whey formula (group We), and 23 infants with a mean age of 17 (95% confidence interval, 4 to 7) months, who were given an amino acid-derived formula (group AA).

Results: Both formulas were clinically and biochemically tolerated. The mean concentration of essential amino acids in plasma was lower in group We but higher in group AA compared with values for breast-fed control infants (p = 0.001). There was a different trend between the groups in weight (p = 0.09) and length (p = 0.006). Growth was promoted in group AA during the follow-up; it was constant during the first months, followed by a gradual decline in rate in group We. In both groups, atopic eczema improved significantly and progressively, and a downward trend was found in serum total and milk-specific IgE concentrations, proving the efficacy of both formulas.

Conclusions: Extensively hydrolyzed formulas are safe and effective for most infants; an amino acid-derived formula may be preferable for infants with multiple food allergies, especially for the maintenance of normal growth.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amino Acids*
  • Animals
  • Dermatitis, Atopic / diagnosis
  • Double-Blind Method
  • Follow-Up Studies
  • Food, Formulated*
  • Humans
  • Infant
  • Infant Food*
  • Lactoglobulins / analysis
  • Milk*
  • Placebos
  • Severity of Illness Index


  • Amino Acids
  • Lactoglobulins
  • Placebos