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Bifidobacterium breve M-16V as a Probiotic for Preterm Infants: A Strain-Specific Systematic Review
Gayatri Athalye-Jape1,2,3, Shripada Rao1,2,3, Karen Simmer1,3
1Department of Neonatal Paediatrics, King Edward Memorial Hospital, Perth, Australia.
Insights
Bifidobacterium breve M-16V shows potential benefits for preterm infants, including reduced late-onset sepsis and mortality, according to non-randomized trials. However, randomized controlled trials found no significant benefits, highlighting the need for more research on this probiotic.
Area of Science:
- Neonatal Medicine
- Microbiology
- Clinical Trials
Background:
- Bifidobacterium breve M-16V is a probiotic used in preterm infants.
- Strain-specific data are crucial for guiding clinical decisions regarding probiotic use.
Purpose of the Study:
- To systematically evaluate the effects of Bifidobacterium breve M-16V in preterm neonates.
- To assess the safety and efficacy of B. breve M-16V in this vulnerable population.
Main Methods:
- A systematic review and meta-analysis of randomized controlled trials (RCTs) and non-RCTs.
- Searched multiple databases and conference proceedings up to January 2017.
- Included 5 RCTs (n=482) and 4 non-RCTs (n=2496).
Main Results:
- Meta-analysis of RCTs (high/unclear risk of bias) showed no significant benefits for necrotizing enterocolitis, late-onset sepsis, mortality, or time to full feeds.
- Meta-analysis of non-RCTs indicated significant benefits in reducing late-onset sepsis (OR=0.56), mortality (OR=0.61), and accelerating time to full feeds (MD=-2.42 days).
- No adverse effects were reported; however, the overall quality of evidence was deemed very low.
Conclusions:
- Current evidence on the efficacy of Bifidobacterium breve M-16V in preterm neonates is limited and of very low quality.
- Further high-quality, adequately powered studies, preferably cluster RCTs, are necessary to confirm potential benefits and guide clinical practice.
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.
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