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Abstract
The purpose of this study was to determine whether a new casein hydrolysate infant
formula, Alimentum, could be administered safely to children with cow milk hypersensitivity.
The formula was analyzed by sodium dodecyl sulfate-polyacrylamide gel electrophoresis
and with a sensitive enzyme-linked inhibition immunoassay, and it was judged to be
safe for clinical trials in children allergic to cow milk. Twenty-five such children
underwent double-blind placebo-controlled oral food challenges with 10 gm of powdered
cow milk and casein hydrolysate formula. All children were highly atopic and had positive
skin prick reactions to cow milk. No patient reacted to placebo during a double-blind,
placebo-controlled food challenge. Two patients lost their allergy to cow milk and
did not react during the challenge; the remaining patients reacted with a variety
of cutaneous, respiratory, and gastrointestinal symptoms within 15 to 90 minutes of
challenge. All children tolerated the blinded challenge to the casein hydrolysate
and were fed the hydrolysate openly without difficulty. We conclude that this casein
hydrolysate is generally safe to feed to children with immediate hypersensitivity
to cow milk. We recommend that all infant formulas promoted as "hypoallergenic" be
tested in milk-allergic patients to assess their allergenic potential, in addition
to standard nutritional evaluation and animal testing for antigenicity.