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

Abstract

Objective To evaluate whether probiotic supplementation attenuates gut-dysbiosis in neonates with congenital gastrointestinal surgical conditions (CGISC). Methods Sixty-one neonates (≥35 weeks gestation) with CGISC were randomised to receive daily supplementation with a triple-strain bifidobacterial probiotic ( n = 30) or placebo ( n = 31) until discharge. Stool microbiota was analysed using 16S ribosomal RNA gene sequencing on samples collected before (T1), 1 week (T2), and 2 weeks (T3) after supplementation and before discharge (T4). The primary outcome was the sum of the relative abundance of potentially pathogenic families of Clostridiaceae , Enterobacteriaceae , Enterococcaceae , Pseudomonaceae , Staphylococcaeae , Streptococcaceae , and Yersiniaceae at T3. Results The median gestational age [38 weeks (IQR: 37.1–38.9)] was similar in both groups. The probiotic group had lower rates of caesarean deliveries (40% versus 70%, p = 0.02). The relative abundance of potentially pathogenic families was lower in the probiotic group compared to placebo at T3 [(median: 50.4 (IQR: 26.6–67.6) versus 67.1 (IQR: 50.9–96.2); p = 0.04). Relative abundance of Bifidobacteriaceae was higher in the probiotic group at T3 [(median: 39.8 (IQR: 24.9–52.1) versus 0.03 (IQR 0.02–2.1); p < 0.001). Stratified analysis continued to show a higher abundance of Bifidobacteriaceae in the probiotic group, irrespective of the mode of delivery. Conclusions Probiotic supplementation attenuated gut dysbiosis in neonates with CGISC. Trial registration http://www.anzctr.org.au (ACTRN12617001401347). Impact Probiotic supplementation attenuates gut dysbiosis and improves stool short-chain fatty acid levels in neonates with congenital gastrointestinal surgical conditions. This is the second pilot RCT of probiotic supplementation in neonates with congenital gastrointestinal conditions. These findings will pave the way for conducting multicentre RCTs in this area.

Probiotic effect in preterm neonates with sepsis - A systematic review protocol

“…Probiotic supplementation has become increasingly popular in the fight against gut microbiota depletion. 16,20,21 A randomized control trial was conducted by Zhong et al to assess the impact of probiotic supplements on 90 neonates with gestational age ≥ 37 weeks. The study concluded that antibiotics cause a decrease in the microbial richness and variety of the gut microbiota in neonates and the attenuation of several bacteria, especially Bifidobacterium and Lactobacillus.…”

“…14,15 A relative reduction in the Bifidobacteriaceae counts and an increase in Enterobacteriaceae and Clostridiaceae may be a good criterion to define dysbiosis in the initial months of life. 11,16 It can also explain gut colonization between birth, which can serve as the basis for introducing nutritional strategies targeted at the microbiota. These nutritional interventions, based mainly on probiotics, may be used for favourably altering the gut microbiome and preventing neonatal sepsis.…”

Probiotic supplementation for neonates with congenital gastrointestinal surgical conditions: guidelines for future research

“…Our pilot RCT found that the head circumference growth was better in the probiotic group. 1 Hence, one could hypothesise that the probiotic supplemented group will have better neurodevelopmental outcomes. Our retrospective study 5 with a sample size of 400 found the incidence of suboptimal neurodevelopmental outcomes to be 16% in term and near-term infants with CGISC.…”

“…Our pilot randomised controlled trial (RCT) 1 found that supplementation with the three-strain probiotic containing Bifidobacterium breve M-16V, Bifidobacterium longum subsp. infantis M-63 and Bifidobacterium longum subsp.…”

“…Based on the experience gained from our pilot RCT, 1 we make the following suggestions for designing future RCTs to overcome the above uncertainties. Some of the suggestions are general and could be used for probiotic RCTs in other population such as preterm infants for prevention of necrotising enterocolitis (NEC).…”