The future of probiotics in the preterm infant

Probiotic administration to preterm infants is not universal despite randomised trial data from >10,000 infants, significant observational data and multiple meta-analyses. Advocates point to reductions in necrotising enterocolitis and sepsis, 'sceptics' hold concerns over data quality/interpretation or risks. Issues revolve around different products, primary outcomes, uncertain dosing strategies and individual large 'negative' trials alongside probiotic associated sepsis and quality control concerns. We review concerns and how to move probiotic use forward. Surprisingly little is known about parental perspectives, vital to inform next steps. How to share information and decisions around probiotic use now, and how this impacts on future available strategies is discussed. We address placebo controlled trials and propose alternate designs, including head to head studies, using 'routine' data collection systems, opt out consents and 'learning technologies' embedded in health care systems. We also raise the importance of underpinning mechanistic work to inform future trials.