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.
| Original language | English |
|---|---|
| Pages (from-to) | 677-688 |
| Number of pages | 12 |
| Journal | Journal of Parenteral and Enteral Nutrition |
| Volume | 42 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 1 May 2018 |
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Bifidobacterium breve M-16V as a Probiotic for Preterm Infants : A Strain-Specific Systematic Review. / Athalye-Jape, Gayatri; Rao, Shripada; Simmer, Karen; Patole, Sanjay.
In: Journal of Parenteral and Enteral Nutrition, Vol. 42, No. 4, 01.05.2018, p. 677-688.Research output: Contribution to journal › Review article
TY - JOUR
T1 - Bifidobacterium breve M-16V as a Probiotic for Preterm Infants
T2 - A Strain-Specific Systematic Review
AU - Athalye-Jape, Gayatri
AU - Rao, Shripada
AU - Simmer, Karen
AU - Patole, Sanjay
PY - 2018/5/1
Y1 - 2018/5/1
N2 - 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.
AB - 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.
KW - Bifidobacterium breve
KW - meta-analysis
KW - necrotizing enterocolitis
KW - preterm infants
KW - systematic review
UR - http://www.scopus.com/inward/record.url?scp=85042908018&partnerID=8YFLogxK
U2 - 10.1177/0148607117722749
DO - 10.1177/0148607117722749
M3 - Review article
VL - 42
SP - 677
EP - 688
JO - Journal of Patenteral and Enternal Nutrition
JF - Journal of Patenteral and Enternal Nutrition
SN - 0148-6071
IS - 4
ER -