These are some of the key findings of a new meta-analysis from China that assessed 44 studies - 30 randomised clinical trials of 8,622 patients and 14 observational studies of 13,779 patients.
Writing the in the journal Neonatology, researchers from Shanghai Jiao Tong University noted the trials were highly variable in birth weight, gestational age, dose, timing, and the type of probiotics.
Twenty-nine trials reported data on NEC (stage II-III) in VLBW babies: "The administration of probiotics significantly reduced the incidence of severe NEC,” they wrote.
Likewise, the 14 observational studies came to the same conclusion.
With regard to the effectiveness of probiotics on late-onset sepsis, data from 28 RCTs showed the pooled effect was reduced by 12%.
Eight observational studies found probiotics reduced the incidence of sepsis in VLBW infants by 19%.
Meanwhile, 27 RCTs reported on overall mortality.
“The administration of probiotics significantly reduced the rate of mortality in the VLBW infants (typical RR 0.77, 95% CI 0.65-0.92, p = 0.003). [In observational studies] the administration of probiotics significantly reduced the incidence of mortality in VLBW infants (RR 0.71, 95% CI 0.62-0.81, p < 0.00001),” they added.
However, the effect of probiotics among ELBW infants was less clear.
Three RCTs showed no statistically significant decrease of severe stage II-III NEC, sepsis or mortality. Two observational studies involving 518 babies showed a reduction in the risk of NEC, however, this was not statistically significant.
“To some, probiotics appear to be the miracle cure of this century due to the fact that their use has been suggested to prevent severe NEC, late-onset sepsis, and to decrease mortality in preterm infants. However, is it really appropriate to say that this is the “golden age” of probiotics in preterm infants?,” asked the researchers.
While arguing the meta-analysis found the use of probiotics in VLBW infants was associated with a statistically significant decreased incidence of NEC, late-onset sepsis, and mortality, they added there was still insufficient clinical trial data available on which to consider the merits of both the safety and efficacy of providing probiotics to ELBW infants.
They also pointed to the wide range of probiotic strains used in neonatology and their conflicting results.
“Combinations containing L. acidophilus together with B. infantis or more should be strongly considered, as the available evidence does not support the single-strain use of L. reuteri, B. breve or S. boulardii. Analysing the different strands, the use of a 2-probiotic combination (L. acidophilus with B. infantis) proved to be statistically significant in reducing NEC and mortality when compared to other probiotic combinations,” they wrote.
They also said there was a need for “greater quality evidence” in terms of the preparation, dosage, and timing of probiotic supplementation in VLBW infants.
Source: Neonatology 2017;112:9-23
“The ‘Golden Age’ of Probiotics: A Systematic Review and Meta-Analysis of Randomized and Observational Studies in Preterm Infants
Author: Dermyshi E, et al
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