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

Our pilot RCT found that probiotic supplementation with the three-strain bifidobacterial product (B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536) attenuates gut dysbiosis, increases stool short-chain fatty acid (SCFA) levels and improves the growth of head circumference in neonates with congenital gastrointestinal surgical conditions (CGISC). In this article, we have provided guidelines for designing future multicentre RCTs based on the experience gained from our pilot RCT. The recommendations include advice about sample size, potential confounders, outcomes of interest, probiotic strain selection, storage, dose, duration and microbial quality assurance, collection of stool samples, storage and analysis and reporting. Following these guidelines will increase the validity of future RCTs in this area and hence confidence in their results. Impact Probiotic supplementation attenuates gut dysbiosis, increases stool short-chain fatty acid (SCFA) levels and improves the growth of head circumference in neonates with congenital gastrointestinal surgical conditions. The current review provides evidence-based guidelines to conduct adequately powered RCTs in this field.

Automated summary

This article presents a pilot randomized controlled trial (RCT) that demonstrates the positive effects of probiotic supplementation in neonates with congenital gastrointestinal surgical conditions. The supplementation attenuates gut dysbiosis, increases levels of short-chain fatty acids in stool, and improves the growth of head circumference. The article also provides evidence-based guidelines for the design of future multicenter RCTs in this field.