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 .
Bacillus clausii for Prevention of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
BACKGROUND OF THE STUDY Preterm infants are managed with antibiotics for sepsis , including suspected or probable sepsis . This leads to a delayed and abnormal colonization of the gut with potentially pathogenic organisms and a microbiome , which lacks biodiversity and increases the risk for late-onset sepsis ( LOS ) . Probiotics have been proven to reduce the risk for necrotizing enterocolitis , but evidence for prevention of LOS is inconclusive . Probiotic effect depends also on the strain used , dose and indication for use . This study evaluated Bacillus clausii probiotic administered prophylactically to preterm neonates for prevention of LOS . OBJECTIVES To study B.clausii given prophylactically to preterm neonates for prevention of LOS . DESIGN Double-blinded , placebo-controlled , r and omized trial . SETTING S Tertiary care neonatal unit in India . PARTICIPANTS Consecutive preterm neonates < 34 weeks , admitted from 1 March 2012 to 28 February 2014 were stratified as extreme preterm and very preterm . INTERVENTION R and omized to receive either probiotic or placebo for 6 weeks , discharge from hospital , death or occurrence of sepsis , whichever was earlier . PRIMARY OUTCOME Incidence of definite and probable LOS in probiotic group compared with placebo . RESULTS Of 326 eligible preterm infants , 244 were enrolled and 82 were excluded . Of these , 120 were stratified as extreme preterm and r and omized to receive placebo ( n = 59 ) and probiotic ( n = 61 ) . Of 124 babies stratified as very preterm , an equal number was r and omized to receive placebo ( n = 62 ) and probiotic ( n = 62 ) . There was no significant difference in the incidence of LOS between the two arms in the extreme preterm group [ 29 % vs. 23 % ; relative risk ( RR ) 1.27 ; 95 % confidence interval ( CI ) 0.88 - 1.66 ; p = 0.36 ] and the very preterm group ( 13 % vs. 10 % ; RR 1.33 ; 95 % CI 0.96 - 1.70 ; p = 0.32 ) . Full feeds were achieved significantly faster in the probiotic group in both the extreme preterm ( RR 0.82 ; 95 % CI 0.74 - 0.88 ) and the very preterm ( RR 0.67 ; 95 % 0.32 - 0.77 ) . CONCLUSIONS Prophylactic administration of B.clausii to preterm neonates did not result in a significant difference in the incidence of LOS as compared with placebo
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 .