Efficacy and safety of an amino-acid-based formula during the period of weaning children with intestinal failure and parenteral nutrition

Introduction: Intestinal failure is the loss of intestinal function due to intestinal diseases, like short bowel syndrome and/or other primary intestinal defects, or to systemic conditions involving the bowel secondarily. Intestinal failure can be reversible or permanent. Patients with intestinal failure require parenteral nutrition for a variable period to survive. It is not well established which formula should be used for weaning from parenteral nutrition. The aim of this study was to assess the impact of a new amino-acid-based formula (Humana SINEALL) on nutritional status and its safety in children with in-testinal failure during 4 weeks of observation. Patients and Methods: We conducted a prospective study in a group of patients aged 2 months to 17 years, followed in our pediatrics department for intestinal failure with different etiologies from October 2007 to February 2008. Nutritional status and feeding tolerance were assessed during 4 weeks of nutritional rehabilitation from parenteral nutrition using the new amino-acid-based formula. For each child we recorded gender, age, body weight, height, body mass index, and serum levels of nutritional biochemical parameters including albumin, prealbumin, iron, ferritin, calcium, and insulin-like growth factor-1. We also tested blood xylose and urinary iodine. All parameters were recorded at the time of enrolment (TO) and after 4 weeks of dietary management (T1). Results: Twenty-two patients (11 males) with a mean age of 4.38 ± 4.63 years were enrolled. Mean z-scored body weight increased from -2.01 ± 0.31 to 0.5 ± 0.98 (p<0.0001) at enrolment (TO) and after 4 weeks of dietary management (T1), respectively. Mean serum albumin levels increased from 2.38 ± 0.62 g/dL to 4.02 ± 0.46 g/dL (p<0.0001); mean prealbumin values from 0.16 ± 0.05 mg/dL to 0.25 ± 0.09 mg/dL (p<0.0006), and mean serum iron levels from 18.08 ± 9.75 pg/dL to 66.62 ± 39.82 pμg/ dL after 4 weeks (p<0.0001); mean calcium values changed from 8.82 ± 1.16 mg/dL to 9.85 ± 1.03 mg/dL (p<0.005); mean insulin-like growth factor-1 increased from 69.75 ± 45.02 ng/mL to 109.89 ± 67.46 ng/mL (p<0.05). The children had mean urinary iodine values of 56.23 ± 27.84 pg/L at TO, which increased after 4 weeks to 119.21 ± 60.8 pg/L (p<0.0001). Mean xylose values of 17.91 ± 10.26 mg% increased to 29.14 ± 11.93 mg% (p<0.005). No side effects were recorded. Conclusions: This new amino-acid-based complete infant formula safely improved nutritional status in our children with intestinal failure during weaning from parenteral nutrition. © 2012 SINPE-GASAPE.