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Abstract

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).

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium breveProbiotic Adherence Variability Based on Host FactorsBeneficial
Large
Bifidobacterium breve Bb-03Reduced Occurrence of Necrotizing Enterocolitis Stage ≥ 2Beneficial
Large
Bifidobacterium breve BBr60Reduced Occurrence of NEC (Bell's Stage 2 or Higher)Beneficial
Large
Bifidobacterium breve BR-03Reduced Occurrence of Necrotizing Enterocolitis Stage ≥ 2Beneficial
Large
Bifidobacterium breve BR03Reduced Occurrence of NEC (Bell's Stage 2 or Higher)Beneficial
Large
Bifidobacterium breve HA-129Probiotic Adherence Variability Based on Host FactorsBeneficial
Large
Bifidobacterium breve IDCC 4401Reduced Occurrence of NEC (Bell's Stage 2 or Higher)Beneficial
Large
Bifidobacterium breve MAK40B22BReduced Occurrence of Necrotizing Enterocolitis Stage ≥ 2Beneficial
Large
Bifidobacterium breve R0070Reduced Occurrence of Necrotizing EnterocolitisBeneficial
Large
Bifidobacterium breve SD5206Reduced Occurrence of Necrotizing EnterocolitisBeneficial
Large
Bifidobacterium breve UABbr-11Reduced Occurrence of Necrotizing Enterocolitis Stage ≥ 2Beneficial
Large
Bifidobacterium breve VPro 52Probiotic Adherence Variability Based on Host FactorsBeneficial
Large
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