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Hypoallergenicity and Effects on Growth and Tolerance of a New Amino Acid–based Formula with DHA and ARA

Vanderhoof, Jon A

Journal of Pediatric Gastroenterology and Nutrition: November 2008 - Volume 47 - Issue - p S60–S61
doi: 10.1097/01.mpg.0000338817.90180.a0
ORIGINAL ARTICLES
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Nutramigen AA is an amino acid-based formula for infants with multiple food protein intolerance or severe cow's milk allergy. Similar growth, tolerance, and safety profiles were found in a study comparing Nutramigen AA with a control formula (Nutramigen LIPIL) in healthy, term, formula-fed infants in a randomised study. Moreover, no allergic reactions were observed in a double-blind, placebo-controlled food challenge in infants or children randomised to receive Nutramigen AA or placebo (Neocate). In conclusion, Nutramigen AA sustains growth and is well tolerated in babies with cow's milk allergy.

Vice President, Global Medical Affairs, Mead Johnson Nutritionals, Evansville, IN, USA

Nutramigen AA is a new amino acid (AA) formula for infants with multiple food protein intolerance or severe cow's milk allergy (CMA). The effects of the new AA-based formula on growth and tolerance in healthy term infants have been compared with those of a casein extensively hydrolysed formula (both with docosahexaenoic [DHA] and arachidonic [ARA] acid levels similar to worldwide human milk levels) (1). A total of 164 healthy term formula fed infants were randomised to either AA-based (Nutramigen) or control formula (Nutramigen LIPIL) and evaluated at regular intervals from 14 days of age up to 120 days of age. Overall growth (Fig. 1), tolerance, and safety profiles were similar between the 2 formulas.

FIG. 1

FIG. 1

The hypoallergenicity of the new AA-based formula (Nutramigen AA) was also evaluated in 29 infants and children with confirmed CMA. Infants and children were randomised and challenged to receive placebo (Neocate) or the new AA-based formula using a double-blind placebo-controlled food challenge, followed by an open challenge with the experimental formula in case of a negative double-blind placebo-controlled food challenge. Infants or children without a reaction were then fed study formula for 7 days to assess long-term tolerance. No allergic reactions were observed in any participant during the double-blind and open food challenges and the extended follow-up period; 1 participant was lost to follow-up. It is important to note that 83% of parents were satisfied with the children's acceptance and tolerance of the AA-based formula.

In summary, the new AA-based formula (Nutramigen AA) has been shown to sustain adequate growth and be well tolerated by babies with CMA.

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REFERENCE

1. Burks W, Hones SM, Berseth CL, et al. Hypoallergenicity and effects on growth and tolerance of a new amino-acid based formula with DHA and ARA. J Pediatr 2008; 153:266–271.
© 2008 Lippincott Williams & Wilkins, Inc.