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Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants

Carol Lynn Berseth1, Susan Hazels Mitmesser1*, Ekhard E Ziegler2, John D Marunycz1 and Jon Vanderhoof1

Author Affiliations

1 Mead Johnson Nutrition, 2400 W. Lloyd Expressway, Evansville, Indiana, 47721, USA

2 Department of Pediatrics, University of Iowa Children's Hospital, Iowa City, Iowa 52242, USA

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Nutrition Journal 2009, 8:27  doi:10.1186/1475-2891-8-27

Published: 19 June 2009



Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life.


The objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy, term infants. Infants (335) were randomized to receive either a standard intact cow milk protein formula (INTACT) or a partially hydrolyzed cow milk protein formula (PH) in a 60 day non-inferiority trial. Discontinuance due to study physician-assessed formula intolerance was the primary outcome. Secondary outcomes included number of infants who discontinued for any reason, including parent-assessed.


Formula intolerance between groups (INTACT, 12.3% vs. PH, 13.7%) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance. Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants (14.4 vs.11.1%) was significantly different (P = 0.001).


This study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy, term infants over a 60-day feeding trial, suggesting nonstandard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants. Parents frequently perceived infant behavior as formula intolerance, paralleling previous reports of unnecessary formula changes.

Trial Registration NCT00666120