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Safety of casein hydrolysate formula in children with cow milk allergy
H A Sampson1, J Bernhisel-Broadbent, E Yang
1Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Insights
A new casein hydrolysate infant formula was tested in children with cow milk hypersensitivity. The formula proved safe for most, with recommendations for further testing of hypoallergenic formulas.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Nutrition
- Food Science
Background:
- Cow milk hypersensitivity is a common concern in infants.
- Assessing the safety of specialized infant formulas is crucial for allergic children.
- Hypoallergenic formulas aim to reduce allergic reactions in sensitive infants.
Purpose of the Study:
- To evaluate the safety and tolerability of a novel casein hydrolysate infant formula (Alimentum) in children with diagnosed cow milk hypersensitivity.
- To determine if the casein hydrolysate formula can be safely administered to this vulnerable population.
- To assess the allergenic potential of the new formula through clinical challenge.
Main Methods:
- Casein hydrolysate formula analyzed for antigenicity using SDS-PAGE and ELISA.
- Double-blind, placebo-controlled oral food challenges conducted with 25 atopic children allergic to cow milk.
- Children received cow milk, placebo, and the casein hydrolysate formula.
- Reactions monitored for cutaneous, respiratory, and gastrointestinal symptoms.
Main Results:
- The casein hydrolysate formula was confirmed safe via laboratory analysis.
- No children reacted to the placebo.
- All 25 children tolerated the casein hydrolysate formula challenge.
- Two children showed a loss of cow milk allergy during the study.
- The remaining children experienced expected allergic reactions to cow milk, not the hydrolysate.
Conclusions:
- The tested casein hydrolysate infant formula is generally safe for children with immediate hypersensitivity to cow milk.
- Standardized testing of "hypoallergenic" infant formulas in milk-allergic patients is recommended.
- Further evaluation beyond nutritional and animal testing is vital for assessing formula safety in allergic infants.
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.