THE CLINICAL EFFECT OF A NEW INFANT FORMULA IN TERM INFANTS WITH CONSTIPATION: A DOUBLE‐BLIND, RANDOMIZED TRIAL.

Abstract

Introduction: Nutrilon Omneo, a new infant formula, contains in comparison to standard infant formula a higher concentration of ß-palmitic acid (>40%) to mimic human milk. Furthermore, it contains galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS), that have been shown to have a prebiotic effect (0,8 g/100 ml GOS/FOS 9:1™). It is hypothesized that a high concentration of ß-palmatic acid and addition of specific oligosaccharides will positively affect stool characteristics in constipated infants. Methods: 38 constipated infants between 3-20 weeks of age were included and randomized by a computer program to one of two infant formulas (Nutrilon Omneo n = 20; Nutrilon1 n = 15) Constipation was defined by the presence of at least one or more of the following symptoms: 1) frequency of defecation <3/week; 2) hard stool consistency; 3) painful defecation (crying); 4) abdominal or rectal palpable mass. Primary outcome measures were defaecation frequency, stool consistency, painful defaecation (crying) and abdominal and rectal palpable mass at 3 weeks. Secondary outcome measure was formula tolerance. Results: A total of 35 infants completed the study. The defecation frequency increased significantly (Nutrilon Omneo: 3.5/w pre and 5.6/w post treatment; Nutrilon1: 3.5/w pre and 4.9/w post treatment)(p < 0.001), but was not different between the two feeding groups (CI: -1.11-2.60; p = 0.42). However, infants receiving Nutrilon Omneo had significantly softer stools than Nutrilon1-fed infants (53% versus 29% respectively; RR 1.42; CI 0.98-2.06; p = 0.03). No difference was found in painful defaecation or the presence of an abdominal or rectal mass between the 2 groups. There were no serious adverse effects reported during the study in either group. Conclusion: The addition of high concentration ß-palmatic acid and specific oligosaccharides in Omneo resulted in softer stools in constipated infants, but not in an increase in stool frequency. Therefore changing from standard infant formula to Nutrilon Omneo should be considered as a first treatment step in constipated infants with hard stools.