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      Probiotics for the prevention of surgical necrotising enterocolitis: systematic review and meta-analysis

      1 , 2 , 3 , 1

      BMJ Paediatrics Open

      BMJ Publishing Group

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          Abstract

          Aim of the study

          Probiotic administration to preterm infants has the potential to prevent necrotising enterocolitis (NEC). Data from randomised controlled trials (RCT) are conflicting but meta-analyses seem to support this intervention. To date, these analyses have not focused on surgical NEC. We aimed to determine the effect of probiotic administration to preterm infants on prevention of surgical NEC.

          Methods

          A systematic review of RCTs of probiotic administration to preterm infants was performed. Studies were included if RCT outcomes included any of (1) Bell’s stage 3 NEC; (2) surgery for NEC; and (3) deaths attributable to NEC. Article selection and data extraction were performed independently by two authors; conflicts were adjudicated by a third author. Data were meta-analysed using Review Manager V.5.3. A random effects model was decided on a priori because of the heterogeneity of study design; data are risk ratio (RR) with 95% CI.

          Main results

          Thirty-five RCTs reported NEC as an outcome. Seventeen reported surgical NEC; all RCTs were included. A variety of probiotic products was administered across studies. Description of surgical NEC in most studies was poor. Only 6/16 specifically reported incidence of surgery for NEC, 12/17 Bell’s stage 3 and 13/17 NEC-associated mortality. Although there was a trend towards probiotic administration reducing stage 3 NEC, this was not significant (RR 0.74 (0.52–1.05), p=0.09). There was no effect of probiotics on the RR of surgery for NEC (RR 0.84 (0.56–1.25), p=0.38). Probiotics did, however, reduce the risk of NEC-associated mortality (RR 0.56 (0.34–0.93), p=0.03).

          Conclusion

          Despite 35 RCTs on probiotic prevention of NEC, evidence for prevention of surgical NEC is not strong, partly due to poor reporting. In studies included in this meta-analysis, probiotic administration was associated with a reduction in NEC-related mortality.

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          Most cited references 50

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          Updated meta-analysis of probiotics for preventing necrotizing enterocolitis in preterm neonates.

          Systematic reviews of randomized, controlled trials (RCTs) indicate lower mortality and necrotizing enterocolitis (NEC) and shorter time to full feeds after probiotic supplementation in preterm ( or =7 days in preterm VLBW neonates and reported on stage 2 NEC or higher (Modified Bell Staging). A total of 11 (N = 2176), including 4 new (n = 783), trials were eligible for inclusion in the meta-analysis by using a fixed-effects model. The risk for NEC and death was significantly lower. Risk for sepsis did not differ significantly. No significant adverse effects were reported. Trial sequential analysis) showed 30% reduction in the incidence of NEC (alpha = .05 and .01; power: 80%). The results confirm the significant benefits of probiotic supplements in reducing death and disease in preterm neonates. The dramatic effect sizes, tight confidence intervals, extremely low P values, and overall evidence indicate that additional placebo-controlled trials are unnecessary if a suitable probiotic product is available.
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            Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial.

            Probiotics may reduce necrotising enterocolitis and late-onset sepsis after preterm birth. However, there has been concern about the rigour and generalisability of some trials and there is no agreement about whether or not they should be used routinely. We aimed to test the effectiveness of the probiotic Bifidobacterium breve BBG-001 to reduce necrotising enterocolitis, late-onset sepsis, and death in preterm infants.
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              Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates.

              To test the hypothesis that normalizing the intestinal flora by administration of prophylactic probiotics would provide a natural defense, thereby reducing both the incidence and severity of necrotizing enterocolitis (NEC) in preterm neonates. Neonates < or =1500 g birth weight were randomized to either receive a daily feeding supplementation with a probiotic mixture (Bifidobacteria infantis, Streptococcus thermophilus, and Bifidobacteria bifidus; Solgar, Israel) of 10(9) colony forming units (CFU)/day or to not receive feed supplements. NEC was graded according to Bell's criteria. For 72 study and 73 control infants, respectively, birth weight (1152 +/- 262 g vs 1111 +/- 278 g), gestational age (30 +/- 3 weeks vs 29 +/- 4 weeks), and time to reach full feeds (14.6 +/- 8.7 days vs 17.5 +/- 13.6 days) were not different. The incidence of NEC was reduced in the study group (4% vs 16.4%; P=.03). NEC was less severe in the probiotic-supplemented infants (Bell's criteria 2.3 +/- 0.5 vs 1.3 +/- 0.5; P=.005). Three of 15 babies who developed NEC died, and all NEC-related deaths occurred in control infants. Probiotic supplementation reduced both the incidence and severity of NEC in our premature neonatal population.
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                Author and article information

                Journal
                BMJ Paediatr Open
                BMJ Paediatr Open
                bmjpo
                bmjpo
                BMJ Paediatrics Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2399-9772
                2017
                1 November 2017
                : 1
                : 1
                Affiliations
                [1 ]UCL Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust , London, UK
                [2 ]departmentDepartment of Paediatric Surgery and Urology, Faculty of Medicine , University of Southampton , Southampton, UK
                [3 ]departmentLondon School of Medicine and Dentistry , Homerton University Hospital and Barts , London, UK
                Author notes
                [Correspondence to ] Dr Simon Eaton; s.eaton@ 123456ucl.ac.uk
                Article
                bmjpo-2017-000066
                10.1136/bmjpo-2017-000066
                5862194
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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