title: Evaluation of a free amino acid-based formula in infants with presumptive food protein-induced proctocolitis.
abstract: OBJECTIVE
  Food protein-induced proctocolitis usually occurs early in life and is characterized by blood-streaked stools and pain during defecation in an otherwise healthy infant. While many infants with food protein-induced proctocolitis respond well to a casein hydrolysate formula, some require an amino acid-based formula. The objective of the study was to measure the change in physician-rated symptom score from enrollment to study completion in infants with presumptive food protein-induced proctocolitis fed with a specific amino acid-based formula.
  
  
  METHODS
  In this study, infants ≤6 months of age diagnosed with presumptive food protein-induced proctocolitis received an amino acid-based formula for 42 days. Intake, stool patterns, weight, stool occult blood, and questionnaires assessing infant feeding and stool patterns and parental formula satisfaction were collected.
  
  
  RESULTS
  The full analysis set included 43 infants. The mean age at enrollment was 59 ± 5 days. A significant improvement was observed from enrollment to exit in physician-rated symptom score (9.1 ± 0.5 to 4.8 ± 0.5, p < 0.0001), the number of infants with occult blood in stool, and weight-for-age Z-scores during the study. Parental satisfaction with the formula was high.
  
  
  CONCLUSIONS
  The results confirm that the amino acid-based formula studied is efficacious for managing symptoms of presumptive food protein-induced proctocolitis.
authors.affiliation: Scientific & Medical Affairs, Abbott Nutrition, Abbott Laboratories, Columbus, OH, USA.
authors.forename: Marlene W
authors.initials: MW
authors.lastname: Borschel
authors.affiliation: Division of Pediatric Gastroenterology, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: Dean L
authors.initials: DL
authors.lastname: Antonson
authors.affiliation: Neonatal Cares, PC, Omaha, NE, USA.
authors.forename: Nancy D
authors.initials: ND
authors.lastname: Murray
authors.affiliation: Department of Pediatrics, TheJohnsHopkinsUniversitySchool of Medicine, Baltimore, MD, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Oliva-Hemker
authors.affiliation: The JohnsHopkinsHospital, Baltimore, MD, USA.
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Mattis
authors.affiliation: Scientific & Medical Affairs, Abbott Nutrition, Abbott Laboratories, Columbus, OH, USA.
authors.forename: Geraldine E
authors.initials: GE
authors.lastname: Baggs
keywords: Amino acid–based formula; elemental formula; eosinophilic proctocolitis; food protein–induced proctocolitis; hypoallergenic formula; infant; infant formula