A double-blinded randomized trial on growth and feeding tolerance with Saccharomyces boulardii CNCM I-745 in formula-fed preterm infants.

OBJECTIVE The use of probiotics is increasingly popular in preterm neonates, as they may prevent necrotizing enterocolitis sepsis and improve growth and feeding tolerance. There is only limited literature on Saccharomyces boulardii CNCM I-745 (S. boulardii) in preterm infants. METHOD A prospective, randomized, case-controlled trial with the probiotic S. boulardii (50mg/kg twice daily) was conducted in newborns with a gestational age of 30-37 weeks and a birth weight between 1500 and 2500g. RESULTS 125 neonates were enrolled; 63 in the treatment and 62 in the control group. Weight gain (16.14±1.96 vs. 10.73±1.77g/kg/day, p<0.05) and formula intake at maximal enteral feeding (128.4±6.7 vs. 112.3±7.2mL/kg/day, p<0.05) were significantly higher in the intervention group. Once enteral feeding was started, the time needed to reach full enteral feeding was significantly shorter in the probiotic group (0.4±0.1 vs. 1.7±0.5 days, p<0.05). There was no significant difference in sepsis. Necrotizing enterocolitis did not occur. No adverse effects related to S. boulardii were observed. CONCLUSION Prophylactic supplementation of S. boulardii at a dose of 50mg/kg twice a day improved weight gain, improved feeding tolerance, and had no adverse effects in preterm infants >30 weeks old.