Intolerance to protein hydrolysate infant formulas: an underrecognized cause of gastrointestinal symptoms in infants

J Pediatr. 1997 Nov;131(5):741-4. doi: 10.1016/s0022-3476(97)70103-3.


The purpose of this study was to determine the effectiveness of an amino acid-based infant formula in infants with continued symptoms suggestive of formula protein intolerance while they were receiving casein hydrolysate formula (CHF). Twenty-eight infants, 22 to 173 days of age, were enrolled; each had received CHF for an average of 40 days (10 to 173 days) and continued to have bloody stools, vomiting, diarrhea, irritability, or failure to gain weight, or a combination of these symptoms. Sigmoidoscopy with rectal biopsy was performed in all infants. The infants then received an amino acid-based infant formula, Neocate, for 2 weeks. After 2 weeks of treatment, 25 of the infants demonstrated resolution of their symptoms and underwent challenge with CHF. Of the 25 who were challenged, eight tolerated the CHF and the remainder had recurrence of their symptoms. The histologic features in these infants varied from eosinophilic infiltration to normal. We conclude that not all infants with apparent formula protein-induced colitis respond to CHF and that these infants may have resolution of their symptoms when fed an amino acid-based infant formula.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dietary Proteins / adverse effects*
  • Female
  • Food, Formulated*
  • Humans
  • Infant
  • Infant Nutritional Physiological Phenomena
  • Infant, Newborn
  • Male
  • Proctocolitis / chemically induced*
  • Proctocolitis / diagnosis
  • Proctocolitis / therapy
  • Protein Hydrolysates / adverse effects*
  • Retrospective Studies
  • Sigmoidoscopy


  • Dietary Proteins
  • Protein Hydrolysates