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Effect and Safety of Saccharomyces boulardii for Neonatal Necrotizing Enterocolitis in Pre-term Infants: A Systematic Review and Meta-Analysis.

  • 2020-06-04
  • Journal of tropical pediatrics 67(3)
    • Xia Gao
    • Yan Wang
    • Lingna Shi
    • Weidong Feng
    • Kang Yi

Study Design

Type
Meta-Analysis
Sample size
n = 1,264
Population
pre-term infants
Methods
A comprehensive search was retrieved in six major databases. The search included randomized controlled trials (RCTs) reporting the incidence of NEC (stage ≥ II), sepsis, mortality, feeding intolerance, full feeding days, time to regain birth weight, days of hospitalization and adverse effects. The random model was used to calculate risk ratio (RR), the standard mean difference (SMD) and its 95% confidence interval (95% CI) between the S. boulardii group and control group.

Background and objective

Necrotizing enterocolitis (NEC) is one of the most common and urgent neonatal emergencies in the neonatal intensive care unit. This disease leads to considerable morbidity and mortality; it also imposes a huge financial burden on patient family and society. Thus, Treatment and prevention of NEC are crucial. This meta-analysis aims to investigate the effect and safety of Saccharomyces boulardii for NEC in pre-term infants.

Methods

A comprehensive search was retrieved in six major databases. The search included randomized controlled trials (RCTs) reporting the incidence of NEC (stage ≥ II), sepsis, mortality, feeding intolerance, full feeding days, time to regain birth weight, days of hospitalization and adverse effects. The random model was used to calculate risk ratio (RR), the standard mean difference (SMD) and its 95% confidence interval (95% CI) between the S. boulardii group and control group. Statistical analyses were conducted using Cochrane systematic review software, Rev Man (version 5.3).

Results

In total, 10 RCTs involving 1264 participants met the inclusion criteria. There were significant reductions in the incidence of NEC [RR = 0.56, 95% CI (0.36-0.89)], feeding intolerance [RR = 0.52, 95% CI (0.39-0.68)], full feeding days [SMD = -1.25, 95% CI (-2.06 to -0.45)] and hospitalization days [SMD = -1.33, 95% CI (-2.64 to -0.02)] in the study group compared with the control group. However, there were no significant differences in sepsis [RR = 0.84, 95% CI (0.61-1.17)], death [RR = 1.12, 95% CI (0.46-2.70)] and the time to regain birth weight [SMD = -0.93, 95% CI (-1.88 to 0.03)] between the two groups. The adverse effect of S. boulardii was not reported. The overall methodological quality was evaluated as moderate by the Cochrane Bias Risk Assessment Tool.

Conclusion

According to this evidence we recommend S. boulardii to prevent NEC, reduce the feeding intolerance, shorten the full feeding days and hospitalization days. However, S. boulardii might be invalid on the incidence of sepsis, mortality and the time to regain birth weight.

Registration

This review has been registered to the PROSPERO (International prospective register of systematic reviews) on 5 December 2019 (ID: CRD42019147896).

Research Insights

Adverse Events Reported

  • saccharomyces boulardii→death

    no significant differences in ... death [RR = 1.12, 95% CI (0.46-2.70)]

    Finding
    No significant difference
    Magnitude
    RR = 1.12, 95% CI (0.46-2.70)
    Significant
    No
  • saccharomyces boulardii→sepsis

    there were no significant differences in sepsis [RR = 0.84, 95% CI (0.61-1.17)]

    Finding
    No significant difference
    Magnitude
    RR = 0.84, 95% CI (0.61-1.17)
    Significant
    No
  • saccharomyces boulardii→Overall tolerability

    The adverse effect of S. boulardii was not reported.

    Finding
    Reported
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