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).