Probiotics for Promoting Feed Tolerance in Very Low Birth Weight Neonates - A Randomized Controlled Trial.

OBJECTIVE To measure the efficacy of a probiotic formulation on time to reach full enteral feeds in VLBW (very low birth weight) newborns. DESIGN Blinded randomized control trial. SETTING A tertiary care neonatal intensive care unit (NICU) in Southern India between August 2012 to November 2013. PARTICIPANTS 104 newborns with a birth weight of 750-1499 g on enteral feeds. INTERVENTION Probiotic group (n=52) received a multicomponent probiotic formulation of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii once a day at a dose of 1.25×109 CFU from the time of initiation of enteral feeds till discharge and the control group (n=52) received only breast milk. OUTCOME MEASURE Time to reach full enteral feeds (150 mL/kg/day). RESULTS The mean (SD) time to reach full enteral feeding was 11.2 (8.3) days in probiotic vs. 12.7 (8.9) in no probiotic group; (P=0.4), and was not significantly different between the two study groups. There was a trend towards lower necrotizing enterocolitis in the probiotic group (4% vs. 12%). CONCLUSION Probiotic supplementation does not seem to result in significant improvement of feed tolerance in VLBW newborns.