Safety and adequacy of a semi-elemental formula for children with gastro-intestinal disease

Abstract

A prospective, open trial was conducted to evaluate the nutritional adequacy of a semi-elemental diet in 47 children with functional gastro-intestinal disorders. Nutritional adequacy was assessed based on growth relative to Euro-growth standards for body mass index (BMI)-for-age z-scores and evaluations of blood parameters. Twenty-five patients completed the study. In total, 533 l of "New-Alfare" was consumed during 775 trial-days. The mean intake per infant was 85.8 +/- 26.8 kcal/kg/day or 122.5 +/- 38.3 ml/kg/day. Weight and length evolution during the 4 weeks trial were within normal range. The mean BMI-for-age z-score (P < 0.05) and albumin concentration (P < 0.01) increased significantly after 4 weeks. Plasma threonine concentration decreased significantly (P = 0.01) and the tryptophan concentration increased (P = 0.06). No adverse events related to the study formula were reported. These results show that "New Alfaré" is safe and nutritionally adequate for pediatric patients with gastro-intestinal disease.

Fig. 1

Flow chart of patients in the study

Fig. 2

Mean ± SD plasma amino acid concentration of patients in the PP population. (a) Concentration of essential amino acids and (b) concentration of non-essential amino acids. * indicates t test P ≤ 0.01