Probiotic supplementation in neonates with congenital gastrointestinal surgical conditions: a pilot randomised controlled trial

Pilot randomized controlled trial in term and near-term neonates with congenital gastrointestinal surgical conditions after surgery in a neonatal intensive care unit. For the probiotic arm, 30 participants were randomized; allocation was 30:31 for probiotic:placebo, and the study was conducted at Perth Children's Hospital in Western Australia.

The active intervention was a daily probiotic sachet containing Bifidobacterium breve M-16V, Bifidobacterium longum subsp. infantis M-63, and Bifidobacterium longum subsp. longum BB536. Each 1 g sachet provided 1 x 10^9 CFU of each strain for a total dose of 3 x 10^9 CFU per day, given once daily and dissolved in 1.5 mL of expressed breast milk or sterile water for administration via feeding tube or mouth. The comparator was placebo maltodextrin.

Daily probiotic supplementation attenuated postoperative gut dysbiosis in these neonates and appeared safe. At T3, the sum of potentially pathogenic bacterial families was lower with probiotic use, 50.4 (IQR 26.6-67.6) versus 67.1 (IQR 50.9-96.2) with placebo (p = 0.04), while Bifidobacteriaceae abundance was much higher, 39.8 (IQR 24.9-52.1) versus 0.03 (IQR 0.02-2.1) (p < 0.001). Actinobacteria abundance was also higher, 40.1% versus 0.1% (p < 0.0001), and total stool SCFAs were higher at T3 (p = 0.008). No probiotic-related infections occurred, but there were no significant differences in HAI, antibiotic duration, parenteral nutrition, hospital stay, or time to full feeds; head circumference z-scores at discharge showed less postnatal growth restriction in the probiotic group (p = 0.013).

This was a small pilot trial with a single-center neonatal surgical population and mixed underlying gastrointestinal diagnoses, which limits generalizability. Follow-up was relatively short and several clinically important outcomes were null, so the findings mainly support biologic efficacy and safety rather than definitive clinical benefit.