Safety and adequacy of an optimized formula for pediatric patients with cow's milk-sensitive enteropathy.

Aim. Infants and children with cow's milk-sensitive enteropathy are treated with extensively hydrolyzed formulas. A formula (New Alfare) was developed by a protein hydrolysis method that yields an amino acid profile that more closely resembles human milk compared to previous formulas, and contains nucleotides. Methods. The current study was a prospective, open trial aimed at evaluating the safety and nutritional adequacy of this formula for pediatric patients with clinical indications for the enteral use of semi-elemental diet. Safety was measured as normal growth based on Eurogrowth standards for body mass index (BMI)-for-age z-scores, and nutritional adequacy was evaluated based on measurements of blood parameters. Forty-seven patients <32 months old, having a gestational age of ≥26 weeks, and weighing ≥1 500 g were enrolled, and fed with New Alfare for four weeks. Weight, length and blood parameters were measured at the beginning and end of the study. Signs of tolerance to the formula (amount of formula intake, gastrointestinal symptoms and stool characteristics) were recorded daily by the parents. Twenty-five patients completed the study with all measurements. Results. There was a significant increase in the mean BMI-for-age z-score (P<0.05) and albumin concentration (P<0.01) after four weeks. Mean plasma threonine concentration decreased significantly (P=0.01) and the mean tryptophan concentration tended to increase by the end of the study (P=0.06). No adverse events related to the study formula were reported. Conclusions. These results show that New Alfare is safe and nutritionally adequate for pediatric patients with cow's milk-sensitive enteropathy.