[Clinical evaluation of the tolerance for a soy-based special milk formula in children with cow's milk protein intolerance/allergy (CMPI/CMPA)]

Abstract

A study aiming to assess the clinical tolerance of a special follow-up soybean milk formula (Neo-Soyal 2) in children with cow's milk protein intolerance or allergy (CMPI/CMPA) has been conducted in 17 infants and children (9 girls and 8 boys) aged from 6 months to 3 years. All the patients had a past history suggestive of CMPI/CMPA and were fed a restricted hypoallergenic diet with a semi-elemental formula based on protein hydrolysates. At the time of initiation of the study, all the patients were asymptomatic with normal growth while on a semi-elemental diet. The formula with protein hydrolysates was substituted by the test milk (Neo-Soyal 2) and blood samples were taken before and after 2 months. The clinical tolerance to the follow-up soybean formula was considered excellent in 16 children who remained asymptomatic with normal growth velocity. Only one patient developed a severe diarrhoea within 72 hours after introduction of the soybean formula which was stopped. However, after one month he was able to tolerate a certain amount of the soybean milk (240 ml) without symptoms. For all the patients studied, there was no change in the nutritional parameters measured in the blood before and after 2 months of the trial. Likewise, the plasma amino acid levels determined in 2 patients remained unchanged before and after the experimental period. These data indicate that the soybean milk formula used here (Neo-Soyal 2) can be safely given as a substitute of semi-elemental diets during the follow-up of children with CMPI/CMPA after the age of 6 months.