Presented at the Neonatal Society 2004 Spring Meeting.
Costeloe K1,2, Jesudass R2, Al Nakib L2, Whiley R3, Hennessy E1, Wilks M3, Millar M3
1 Barts and the London School of Medicine and Dentistry, London, UK
2 Homerton University Hospital NHS Trust, London, UK
3 Department of Medical Microbiology, Barts and the London NHS Trust, London, UK
Background : The bowel flora of preterm babies is dominated by hospital-acquired, antibiotic resistant and potentially pathogenic species. The early use of probiotics might promote more normal intestinal flora, improve nutritional state and reduce infection.
Objective : To provide pilot data to show whether early daily administration of a probiotic to the VLBW infant is safe and leads to modification of the bowel flora.
Methods : 40 babies <1500g birthweight were randomised to receive daily Bifidobacterium breve strain BBG 109 cfu or placebo for 28d starting within 2d of birth, whether or not enterally fed. Stools to 28d were collected and cultured quantitatively, clinical information was collected throughout the hospital stay.
Results : 22 babies were randomised to probiotic and 18 to placebo, the intervention was well tolerated with no complications. Mean (SD) BWt was 939(226) v 925(277)g. p=.97; gestational age 26.7(1.9) v 27.9(2.3)w. p=.07, boys in the probiotic group 91% v 11%,p<.0001. 4 in the probiotic arm and one in the placebo arm died before discharge, p=.23. The proportion colonised with B.breve increased with postnatal age: 21 v 18% at 5.4(1.7)days, 62 v 31% at 14.7(2.3)days and 81 v 41% at 27.9(3.2) days, chi2 trend p=.012. At 28d rates of stool colonisation were 25% v 16%, p=.13 for anaerobes; 19% v 56%, p=.028 for enterococci; 12.5 v 19%, p=.63 for staphylococci and 100 v 88%, p=.14 for facultative gram negatives mostly resistant to ampicillin. The number of babies having blood culture positive septic episodes was 23 v 44%, p=.25; suspected or proven NEC was diagnosed in 23 v 22%, p=.58. At 36w pma 37 v 71% ,p=.045 were still in oxygen. After controlling for gestational age, babies receiving probiotic achieved full feeds (150ml milk/kg/day for 24h) at 3.7(95%CI -8.2 – + 0.7) days /week gestation sooner and gained weight at 53(95%CI 31 – 76)g/week faster, p<.001.
Conclusions : These preliminary data support the safety of early administration of B.breve strain BBG and show that high rates of colonisation are achieved with daily administration. Colonisation with enterococci was reduced in the probiotic group and there was more microbial diversity. A larger study is needed to test whether the improved clinical outcomes suggested by this study can be confirmed.
Acknowledgements: Ms Jusudass was supported by Homerton University NHS Trust Department of R&D. Probiotic and placebo provided by Yakult