Objective: To determine the hypoallergenicity and efficacy of a pediatric amino acid-based formula (AAF), EleCare, for children with cow's milk allergy (CMA) and multiple food allergies (MFA).
Study design: Hypoallergenicity was determined by performing blinded oral food challenges in 31 consecutive children with documented CMA. Growth, tolerance, and biochemical response were evaluated during a nonrandomized feeding study with each child serving as his or her own control.
Results: Thirty-one children (median age, 23.3 months; range, 6 months to 17.5 years) were recruited; 29 had MFA, 17 had acute reactions and cow's milk-specific IgE antibody, and 14 had allergic eosinophilic gastroenteritis. At study entry, 23 were receiving another AAF; 13 had not tolerated extensively hydrolyzed formula. Eighteen subjects with allergic eosinophilic gastroenteritis and/or MFA were followed up while receiving AAF for a median of 21 months (range, 7 to 40 months), with biochemical analysis performed at 4 months. No statistically significant differences were observed in the change in weight or height National Center for Health Statistics z scores from entry; the percent of expected growth exceeded 90%. There was a small decline in percent eosinophils and increase in hemoglobin, hematocrit, and serum ferritin level (P < .05). Except for small increases in plasma leucine and valine levels (P < or = .006), the remaining biochemical markers were unchanged.
Conclusions: The AAF was hypoallergenic and effective in maintaining normal growth for children with CMA and MFA.