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

2022-01-03
Pediatric research 92(4)
- Shripada Rao
- Meera Esvaran
- Liwei Chen
- Anthony D Keil
- Ian Gollow
- Karen Simmer
- Bernd Wemheuer
- Patricia Conway
- Sanjay Patole

PubMed: 34980887
DOI: 10.1038/s41390-021-01884-x

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 31
Population: 61 neonates (≥35 weeks gestation) with congenital gastrointestinal surgical conditions (CGISC)
Methods: Randomised to receive daily supplementation with a triple-strain bifidobacterial probiotic (n=30) or placebo (n=31) until discharge; stool microbiota 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)
Duration: until discharge

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.