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Efficacy and Safety of Bifidobacterium longum Supplementation in Infants: A Meta-Analysis of Randomized Controlled Trials

  • 2023-12-12
  • Foods 12(24)
    • Huangda Guo
    • Meng Fan
    • Tianjiao Hou
    • Yixin Li
    • Siyue Wang
    • Xueheng Wang
    • Hexiang Peng
    • Mengying Wang
    • Tao Wu
    • Yumei Zhang


Background: Strategies to stabilize and support overall infant health by increasing the number of Bifidobacterium longum in the infant gut are of interest, but few studies have systematically addressed this issue. We aimed to evaluate the efficacy and safety of Bifidobacterium longum use in infants using meta-analysis.

Methods: We searched PubMed, EMBASE, Cochrane Library of Systematic Reviews, and SinoMed for publications until 27 July 2022. The main outcomes of interest were weight gain, risk of necrotizing enterocolitis (NEC), and adverse events. Two authors independently performed study screening, risk of bias assessment, and data extraction. Outcome data were extracted from each included study and combined using mean difference (MD) or risk ratio (RR) and finally combined using a fixed-effect model or random-effect model.

Results: A total of 4481 relevant studies were identified, of which 15 were found to be eligible for randomized controlled trials and were included in the meta-analysis. The combined extracted data showed that the intervention group containing Bifidobacterium longum had a significantly lower risk of NEC (RR = 0.539, 95% CI: 0.333, 0.874) compared to the control group. There was no statistical difference between the intervention and control groups regarding weight gain (MD = 0.029, 95% CI: -0.032, 0.090), the occurrence of adverse events (RR = 0.986, 95% CI: 0.843, 1.153), and serious adverse events (RR = 0.881, 95% CI: 0.493, 1.573).

Conclusions: Bifidobacterium longum may significantly reduce the risk of NEC in infants as well as being safe; thus, further research evidence is needed on whether there is a benefit on weight gain.

Keywords: Bifidobacterium longum; efficacy; meta-analysis; necrotizing enterocolitis; randomized clinical trials; safety.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium longum BI-05Increased Body WeightNeutral
Bifidobacterium longum BI-05Increased Occurrence of Serious Adverse EventsNeutral
Bifidobacterium longum BI-05Occurrence of Adverse EventsNeutral
Bifidobacterium longum BI-05Reduced Risk of Necrotizing EnterocolitisBeneficial

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