PiPS - Probiotics in Preterm babies Study
Preterm babies are at increased risk of episodes of bacterial infection which may be fatal and are associated with chronic complications in survivors. This is largely because preterm babies have immature defences against infection. An important way in which the body is protected is through the 'friendly bacteria' that normally live in the gut. At birth there are no organisms in the gut but healthy babies who are nursed with their mothers quickly become colonised with their 'friendly' bacteria. Preterm babies who are separated from their mother at birth are more likely to become colonised with bacteria in the environment of the Neonatal Unit that may cause disease. It is possible that if these babies are given 'friendly bacteria' (probiotic), these will multiply in the gut, improve the general health of the intestine and reduce the chance of potentially pathogenic organisms becoming established; this should reduce infection. There is some evidence of the beneficial effects of probiotics in the published literature but they have not been adequately tested in a study involving more than one hospital and including the babies at greatest risk. Probiotics do seem to be safe, but again more data are needed.
This randomised trial tested whether giving preterm babies a single probiotic bacterium improved their health and decreased their risk of infection. The main outcomes that were measured were episodes of infection, episodes of necrotising enterocolitis, death, growth, use of antibiotics and length of stay.
- Costeloe K, Hardy P, Juszczak E, Wilks M, Millar MR, Probiotics in Preterm Infants Study Collaborative G. Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet. 2016;387(10019):649-60.
- Millar MR, Seale J, Turton J, Wilks M, Costeloe K, Woodford N, Juszczak E, Whiley A, Panton N, Wareham DW. ESBL-producing Enterobacteriaceae in 24 neonatal units and associated networks in the south of England: no clustering of ESBL-producing Escherichia coli in units or networks. J Antimicrob Chemother. 2016;71(5):1174-7.
- Costeloe KL, Bowler U, Brocklehurst P, Hardy P, Heal P, Juszczak E, King A, Panton N, Stacey F, Whiley A, Wilks M, Millar MR. A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infants (PiPS) trial. Health Technol Assess. 2016;20(66).
- Millar M, Seale J, Greenland M, Hardy P, Juszczak E, Wilks M, Panton N, Costeloe K, Wade WG. The Microbiome of Infants Recruited to a Randomised Placebo-controlled Probiotic Trial (PiPS Trial). EBioMedicine. 2017;20:255-62.