Efficacy and safety of hydrolyzed cow milk and amino acid–derived formulas in infants with cow milk allergy,☆☆,,★★

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Abstract

Objective: To determine the antigenicity, nutritional adequacy, and growth-promoting efficacy of protein hydrolysate or amino acid–derived formulas in infants with cow milk allergy. Study design: Several protein hydrolysate or amino acid–derived formulas were graded for β-lactoglobulin content and skin reactivity in 74 atopic children with cow milk allergy proved by a double-blind, placebo-controlled challenge. A randomized, prospective follow-up study of 9 months included 22 infants with a mean age of 6 months (95% confidence interval, 4 to 7), who were fed an extensively hydrolyzed whey formula (group We), and 23 infants with a mean age of 7 (95% confidence interval, 4 to 7) months, who were given an amino acid–derived formula (group AA). Results: Both formulas were clinically and biochemically tolerated. The mean concentration of essential amino acids in plasma was lower in group We but higher in group AA compared with values for breast-fed control infants (p = 0.001). There was a different trend between the groups in weight (p = 0.09) and length (p = 0.006). Growth was promoted in group AA during the follow-up; it was constant during the first months, followed by a gradual decline in rate in group We. In both groups, atopic eczema improved significantly and progressively, and a downward trend was found in serum total and milk-specific IgE concentrations, proving the efficacy of both formulas. Conclusions: Extensively hydrolyzed formulas are safe and effective for most infants; an amino acid–derived formula may be preferable for infants with multiple food allergies, especially for the maintenance of normal growth. (J PEDIATR 1995; 127:550-7)

Section snippets

Patients and study design

Part 1 of the study was designed to assess the antigenicity of protein hydrolysates and amino acid–derived formulas used in the management of cow milk allergy, and part 2 to observe the clinical and nutritional outcome in infants fed with the chosen formulas.

In part 1 we first determined the β-lactoglobulin concentration in five hydrolysates and two amino acid formulas. Of these formulas, one was made with partially hydrolyzed whey protein, two with extensively hydrolyzed milk proteins (one

Bovine β-lactoglobulin content in protein hydrolysate and amino acid–derived formulas

Table II shows that the β-lactoglobulin content was highest in the partially hydrolyzed whey formula, followed by the amino acid–derived Nutri-Junior formula, the extensively hydrolyzed casein and whey formulas, and the amino acid–derived Neocate formula. In the partially hydrolyzed formula, the β-lactoglobulin content was 2400 to 52,000 times higher than in the others, and in the Nutri-Junior formula it was 20-fold that in the Neocate formula. The values, moreover, were equal in the

DISCUSSION

Management of cow milk allergy includes exclusion of cow milk antigens from the diet. Rigorous elimination preserves the intestinal integrity and prevents aberrant antigen absorption.15 Elimination diets in food-sensitive patients have been shown to reverse the disturbance of the humoral and cell-mediated immune responses, with decreases in the level of allergen-specific IgE and the proliferative response of peripheral blood mononuclear cells to food allergens,16 and improved capacity of

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    From the Departments of Pediatrics, Clinical Physiology, and Dermatology, University of Tampere Medical School and Tampere University Hospital, Tampere, Finland, and the Helsinki University Central Hospital, Hospital for Skin and Allergic Diseases, Helsinki, Finland

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    Supported by the Academy of Finland.

    Reprint requests: Erika Isolauri, MD, Medical School, University of Tampere, P.O. Box 607, 33101 Tampere, Finland.

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