Effect of Bifidobacterium breve M-16V Supplementation on Fecal Bifidobacteria in Preterm Neonates - A Randomised Double Blind Placebo Controlled Trial

Study answer

What this study found

Bifidobacterium breve M-16V increased fecal B. breve colonization in preterm neonates and was well tolerated, with no probiotic sepsis or supplement-related adverse effects observed. In stool sample 2, colonization was 67/74 (91%) with probiotic versus 25/66 (38%) with placebo, and the between-sample change in log10 counts was higher with probiotic, 3.1 (4.3-4.9) versus 0 (3.2-5.0), p<0.001. In stool sample 1, colonization was 29/74 (39%) versus 2/66 (3%). Clinical outcomes such as time to full enteral feeds, length of hospital stay, discharge weight, and sepsis outcomes were not…

Study & population

Randomized, double-blind, placebo-controlled trial in 159 preterm very-low-birth-weight neonates admitted to a tertiary neonatal intensive care unit in Perth, Western Australia, who were up to 32 weeks 6 days' gestation and ready to commence or already receiving enteral feeds for up to 12 hours.

Intervention

Bifidobacterium breve M-16V was given daily by orogastric feeding tube from birth until corrected age 37 weeks.

Key limitation

This was a single-center neonatal trial with a modest sample size and smaller subsets for microbiologic analyses than the randomized groups.

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Original abstract