Bifidobacterium breve M-16V as a Probiotic for Preterm Infants: A Strain-Specific Systematic Review

Gayatri Athalye-Jape, Shripada Rao, Karen Simmer, Sanjay Patole

    Research output: Contribution to journalReview article

    9 Citations (Scopus)

    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 languageEnglish
    Pages (from-to)677-688
    Number of pages12
    JournalJournal of Parenteral and Enteral Nutrition
    Volume42
    Issue number4
    DOIs
    Publication statusPublished - 1 May 2018

    Fingerprint

    Probiotics
    Premature Infants
    Randomized Controlled Trials
    Pediatrics
    Meta-Analysis
    Odds Ratio
    Newborn Infant
    Necrotizing Enterocolitis
    Sepsis
    Bifidobacterium breve
    Databases
    Mortality
    Non-Randomized Controlled Trials

    Cite this

    @article{f9e92dba7aa14bcab27ffdbeec911c42,
    title = "Bifidobacterium breve M-16V as a Probiotic for Preterm Infants: A Strain-Specific Systematic Review",
    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.",
    keywords = "Bifidobacterium breve, meta-analysis, necrotizing enterocolitis, preterm infants, systematic review",
    author = "Gayatri Athalye-Jape and Shripada Rao and Karen Simmer and Sanjay Patole",
    year = "2018",
    month = "5",
    day = "1",
    doi = "10.1177/0148607117722749",
    language = "English",
    volume = "42",
    pages = "677--688",
    journal = "Journal of Patenteral and Enternal Nutrition",
    issn = "0148-6071",
    publisher = "SAGE Publications Ltd",
    number = "4",

    }

    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 journalReview 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 -