Gayatri Athalye-Jape1,2,3, Shripada Rao1,2,3, Karen Simmer1,3, Sanjay Patole1,3. 1. Department of Neonatal Paediatrics, King Edward Memorial Hospital, Perth, Australia. 2. Department of Neonatal Paediatrics, Princess Margaret Hospital for Children, Perth, Australia. 3. Centre for Neonatal Research and Education, School of Paediatrics and Child Health, University of Western Australia, Perth, Australia.
Abstract
INTRODUCTION: Bifidobacterium breve M-16V has been used as a probiotic in preterm infants. Probiotic strain-specific data are essential to guide clinical practice. OBJECTIVE: To assess effects of B breve M-16V in preterm neonates. DESIGN: A systematic review of randomized controlled trials (RCTs) and non-RCTs of B breve M-16V in preterm infants was conducted. Multiple databases, proceedings of Pediatric Academy Society, and other relevant conferences were searched in September 2016 and on January 5, 2017. RESULTS: Five RCTs (n = 482) and 4 non-RCTs (n = 2496) were included. Of the 5 RCTs, 4 carried high/unclear risk of bias in many domains. Meta-analysis (fixed effects model) of RCTs showed no significant benefits on stage ≥2 necrotizing enterocolitis, late-onset sepsis, mortality, and postnatal age at full feeds. Meta-analysis of non-RCTs showed significant benefits on (1) late-onset sepsis-3 studies (n = 2452), odds ratio = 0.56 (95% CI, 0.45-0.71), P < .0001; (2) mortality-2 studies (n = 2319), odds ratio = 0.61 (95% CI, 0.44-0.84), P = .002; and (3) postnatal age at full feeds (days)-2 studies (n = 361), mean difference, -2.42 (95% CI, -2.55 to -2.3), P < .00001. There were no adverse effects from B breve M-16V. On Grading of Recommendations, Assessment, Development, and Evaluation analysis, the overall quality of evidence was deemed very low. CONCLUSIONS: Current evidence is limited regarding the potential of B breve M-16V in preterm neonates. Adequately powered, preferably cluster RCTs are needed to confirm these findings.
INTRODUCTION:Bifidobacterium breve M-16V has been used as a probiotic in preterm infants. Probiotic strain-specific data are essential to guide clinical practice. OBJECTIVE: To assess effects of B breve M-16V in preterm neonates. DESIGN: A systematic review of randomized controlled trials (RCTs) and non-RCTs of B breve M-16V in preterm infants was conducted. Multiple databases, proceedings of Pediatric Academy Society, and other relevant conferences were searched in September 2016 and on January 5, 2017. RESULTS: Five RCTs (n = 482) and 4 non-RCTs (n = 2496) were included. Of the 5 RCTs, 4 carried high/unclear risk of bias in many domains. Meta-analysis (fixed effects model) of RCTs showed no significant benefits on stage ≥2 necrotizing enterocolitis, late-onset sepsis, mortality, and postnatal age at full feeds. Meta-analysis of non-RCTs showed significant benefits on (1) late-onset sepsis-3 studies (n = 2452), odds ratio = 0.56 (95% CI, 0.45-0.71), P < .0001; (2) mortality-2 studies (n = 2319), odds ratio = 0.61 (95% CI, 0.44-0.84), P = .002; and (3) postnatal age at full feeds (days)-2 studies (n = 361), mean difference, -2.42 (95% CI, -2.55 to -2.3), P < .00001. There were no adverse effects from B breve M-16V. On Grading of Recommendations, Assessment, Development, and Evaluation analysis, the overall quality of evidence was deemed very low. CONCLUSIONS: Current evidence is limited regarding the potential of B breve M-16V in preterm neonates. Adequately powered, preferably cluster RCTs are needed to confirm these findings.
Authors: Rebecca L Morgan; Geoffrey A Preidis; Purna C Kashyap; Adam V Weizman; Behnam Sadeghirad Journal: Gastroenterology Date: 2020-06-24 Impact factor: 22.682