Challenge confirmation of late-onset reactions to extensively hydrolyzed formulas in infants with multiple food protein intolerance

J Allergy Clin Immunol. 1995 Sep;96(3):386-94. doi: 10.1016/s0091-6749(95)70058-7.


Background: Many infants with cow's milk protein intolerance have adverse reactions to soy, casein and whey hydrolysate formula and to other foods. The recent development of Neocate, a hypoallergenic, nutritionally complete infant formula composed of individual amino acids and other nutrients, has enabled these infants to be stabilized.

Objective: We observed the effect of food challenges in infants with reported hypersensitivity to hypoallergenic formulas.

Methods: Eighteen infants (median age, 7 1/2 months) were given Neocate formula for 2 months and then underwent a 7-day double-blind placebo-controlled challenge with the formula previously best tolerated.

Results: In 12 of the 18 infants irritability, vomiting, diarrhea, and/or eczema flares developed during the formula challenge. In two patients symptoms developed immediately, but in the remainder adverse reactions evolved within 7 days (range, 4 to 7 days). Adverse reactions were to soy formula (six patients), whey hydrolysate (two), and casein hydrolysate (four). When infants were 12 months of age, parents reported adverse reactions after the ingestion of other low allergen foods (median, six; from a panel of 10 such foods).

Conclusion: A group of infants with late-onset adverse reactions to soy, extensively hydrolyzed casein, and whey formulas and to other foods has been identified. Neocate formula proved to be an effective substitute formula for these patients.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Amino Acids
  • Carbohydrates
  • Caseins / immunology
  • Dietary Fats
  • Double-Blind Method
  • Female
  • Food Hypersensitivity / immunology*
  • Food, Formulated*
  • Humans
  • Hydrolysis
  • Infant
  • Male
  • Milk Proteins / immunology
  • Placebos
  • Protein Hydrolysates / immunology
  • Proteins / immunology*
  • Soybeans / immunology


  • Amino Acids
  • Carbohydrates
  • Caseins
  • Dietary Fats
  • Milk Proteins
  • Neocate
  • Placebos
  • Protein Hydrolysates
  • Proteins