Efficacy of Bifidobacterium breve and Lactobacillus casei oral supplementation on necrotizing enterocolitis in very-low-birth-weight preterm infants: a double-blind, randomized, controlled trial

Background: Probiotics are used for the prevention of necrotizing enterocolitis (NEC) because of their positive effects on intestinal motor function, modulation of inflammatory response, and mucosal barrier function. Objective: The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage >= 2 by the criteria of Bell in very-low-birth-weight preterm infants. Design: A double-blind, randomized, controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth. The intervention group was composed of 119 infants who received human milk with probiotic supplementation (B. breve and L. casei) and a control group of 112 infants who received human milk containing no probiotics. The primary outcome was the occurrence of NEC stage >= 2 as defined by Bell's modified criteria. Results: Four confirmed cases of NEC stage >= 2 by Bell's criteria occurred only in the control group. Conclusions: Oral supplementation of B. breve and L. casei reduced the occurrence of NEC (Bell's stage >= 2). It was considered that an improvement in intestinal motility might have contributed to this result. This trial was registered at www.isrctin.org as number 67165178 (International Standard Randomized Controlled Trial). Am J Clin Nutr 2011;93:81-6.