LIMITATIONS Heterogeneity of organisms and dosing regimens studied prevent a species-specific treatment recommendation from being made .
CONCLUSIONS Preterm infants benefit from probiotics to prevent severe NEC and death
CONTEXT Necrotizing enterocolitis ( NEC ) is the most frequent gastrointestinal emergency in neonates .
The microbiome of the preterm gut may regulate the integrity of the intestinal mucosa .
Probiotics may positively contribute to mucosal integrity , potentially reducing the risk of NEC in neonates .
OBJECTIVE To perform an up date d systematic review and meta- analysis on the efficacy and safety of probiotics for the prevention of NEC in premature infants .
Effect of Bifidobacterium breve M-16V Supplementation on Fecal Bifidobacteria in Preterm Neonates - A Randomised Double Blind Placebo Controlled Trial
Background Probiotic supplementation significantly reduces the risk of necrotising enterocolitis ( NEC ) and all cause mortality  in preterm neonates . Independent quality assessment is important before introducing routine probiotic supplementation in this cohort . Aim To assess product quality , and confirm that Bifidobacterium breve ( B. breve ) M-16V supplementation will increase fecal B. breve counts without adverse effects . Methods and Participants Strain identity ( 16S rRNA gene sequencing ) , viability over 2 year shelf-life were confirmed , and microbial contamination of the product was ruled out . In a controlled trial preterm neonates ( Gestation <33 weeks ) ready to commence or on feeds for < 12 hours were r and omly allocated to either B. breve M-16V ( 3 × 109 cfu/day ) or placebo ( dextrin ) supplementation  until the corrected age 37 weeks . Stool sample s were collected before ( S1 ) and after 3 weeks of supplementation ( S2 ) for study ing fecal B. breve levels using quantitative PCR ( Primary outcome ) . Secondary outcomes included total fecal bifidobacteria and NEC≥Stage II . Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests , and McNemar and Wilcoxon signed-rank tests for paired comparisons . Results A total of 159 neonates ( Probiotic : 79 , Placebo : 80 ) were enrolled . Maternal and neonatal demographic characteristics were comparable between the groups . The proportion of neonates with detectable B. breve increased significantly post intervention : Placebo : [ S1:2/66 ( 3 % ) , S2 : 25/66 ( 38 % ) , p<0.001 ] Probiotic : [ S1 : 29/74 ( 40 % ) , S2 : 67/74 ( 91 % ) , p<0.001 ] . Median S1 B. breve counts in both groups were below detection ( < 4.7 log cells.g−1 ) , increasing significantly in S2 for the probiotic group ( log 8.6 ) while remaining < 4.7 log in the control group ( p<0.001 ) . There were no adverse effects including probiotic sepsis and no deaths . NEC≥Stage II occurred in only 1 neonate ( placebo group ) . Conclusion B. breve M-16V is a suitable probiotic strain for routine use in preterm neonates . Trial Registration Australia New Zeal and Clinical Trial Registry ACTRN
LIMITATIONS Heterogeneity of organisms and dosing regimens studied prevent a species-specific treatment recommendation from being made .
CONCLUSIONS Preterm infants benefit from probiotics to prevent severe NEC and death
CONTEXT Necrotizing enterocolitis ( NEC ) is the most frequent gastrointestinal emergency in neonates .
The microbiome of the preterm gut may regulate the integrity of the intestinal mucosa .
Probiotics may positively contribute to mucosal integrity , potentially reducing the risk of NEC in neonates .
OBJECTIVE To perform an up date d systematic review and meta- analysis on the efficacy and safety of probiotics for the prevention of NEC in premature infants .