PIPS: Probiotics In Preterm babies Study

• Research type

  Research Study

• Full title

  The probiotic Bifidobacterium breve strain BBG-001 administered early to preterm infants to prevent infection, necrotising enterocolitis and death

• IRAS ID

  1037

• Sponsor organisation

  Queen Mary, University of London

• Eudract number

  2006-003445-17

• ISRCTN Number

  To be obtained

• Research summary

  Premature babies are at increased risk of bacterial infection and of the severe intestinal complication, necrotising enterocolitis (NEC); both may be fatal and are associated with increased hospitalisation and chronic complications. This is largely because premature babies have immature defences against infection. An important way in which the body's protected is through the 'friendly bacteria' that normally thrive in the gut and promote its health. At birth the gut is sterile; healthy babies nursed with their mothers quickly become colonised with their 'friendly' bacteria. Premature babies, separated from their mothers at birth, are more likely to become colonised with bacteria in the environment of the Neonatal Intensive Care Unit that may cause disease. We hypothesise that 'friendly bacteria' (probiotics) given soon after birth will multiply in the intestine improving its general health and reducing the chance of potentially pathogenic organisms becoming established. This should reduce infection by organisms invading the bloodstream from the gut and of complications such as NEC. There is some evidence of benefit from probiotics in the published literature and they appear to be safe but the number of babies receiving them is small and we cannot be confident either of their efficacy or safety. None of the studies has taken place in the UK and the babies at greatest risk have been excluded.This proposal describes a study to test the hypothesis described above recruiting nearly 1300 very premature babies over 2.5 years in about 20 hospitals in England, using a simple product containing a single probiotic bacterium started soon after birth compared with a dummy (placebo) product. The main outcomes measured are episodes of blood stream infection, NEC and death. Fully informed parental consent will be obtained before study entry, giving the parents as much time as possible to consider inclusion of their baby.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/30

• Date of REC Opinion

  12 May 2009

• REC opinion

  Further Information Favourable Opinion