Background and aims Most studies show that probiotics are effective in preventing morbidity and mortality in preterm infants. Using network meta-analysis (NMA) we aim to rank treatments’ efficacy and identify the most effective strain, formulation and dose.
Methods Databases searched: CENTRAL, Ovid MEDLINE EMBASE, LILACS and the Cochrane Database of Systematic Reviews. Clinicaltrials.gov; controlled-trials.com; and WHO’s ICTRP were searched for any ongoing studies. Searches completed up to November 2016 without language restriction. Reference checking, citation searching and contact with study authors were done to identify additional studies.
Randomised controlled trials evaluating probiotics interventions and combinations of probiotics/strains of the same probiotic of all durations were included. 2 independent, unblinded review authors assessed the trials for inclusion and extracted data. We used standard methodology as per The Cochrane Collaboration. The protocol was registered – Cochrane Database CD012303, PROSPERO CRD42016047640.
Main results 53 included trials reported outcomes on 13 630 infants. The period of studies was Jan 1986-Oct 2016. All studies enrolled infants<37 weeks, birth weight<2500g or both. The probiotics administered to the intervention groups were different strains of Lactobacillus, Bacillus, Streptococcum, Bifidobacterium, Saccharomyces boulardii or a mixture of probiotics. Most of studies compared intervention and placebo/no treatment.
Our preliminary results from 35 studies (10 063 patients) show evidence of significant reduction in global mortality in probiotics group (10 063 patients, RR 0.77, 95% CI 0.66 to 0.91, I2=0%). Data from 38 studies provide information on severe necrotising enterocolitis (NEC), stage 2 or 3, with a significant reduction in the incidence of NEC with prophylactic administration of probiotics (9455 patients, RR 0.52, 95% CI 0.40 to 0.68, I2=22%). And, data from 35 studies with 10 565 patients informed about any culture proven sepsis, showed a significant reduction in rates of confirmed sepsis (RR 0.82, 95% CI 0.74 to 0.92, I2=33%).
Conclusion Based on our preliminary results, It seems (moderate quality of evidence) that administration of probiotics in preterm infants could reduce NEC, culture proven sepsis and even global mortality. We are currently analysing the most effective strain of probiotic. Further clinical trials of probiotics head to head will be needed to confirm our data.
- Necrotising enterocolitis
- late-onset sepsis
- Systematic review
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