Results from the largest probiotic study to date in premature infants showed
that necrotizing enterocolitis (NEC), the most common gastrointestinal cause of
death and illness in premature infants, decreased by 40% in the infants
supplemented by Lactobacillus reuteri Protectis compared to placebo. Further, in
the infants below 1500 grams Lactobacillus reuteri Protectis reduced episodes of
feeding intolerance by 43%.
The safety of Lactobacillus reuteri Protectis in this high-risk population was
also confirmed, but there was no significant difference between the groups on
the primary outcome, frequency of death or hospital acquired infection.
“Although our study was under-powered to show significant differences in the
primary outcome, the trends are consistent with those observed in meta analyses
on NEC and death”, says Professor Mario A. Rojas, Department of Pediatrics, Wake
Forest School of Medicine, Winston-Salem NC, United States.
“Unfortunately the study was terminated early, but despite this it is now
confirmed that treatment of premature infants with Lactobacillus
reuteri Protectis is both safe and clinically relevant”, says Peter Rothschild,
Chief Executive Officer at BioGaia.
Largest probiotic study in premature infants
A total of 751 infants were included in the study, which was considerably less
than the number planned (1110) and required to reach significance in the outcome
parameters. The study was terminated early, which was related to substantial
drops in recruitment rate and funding restrictions from the independent funding
institute.
In the multi-centre, double-blind, randomised, placebo-controlled trial in nine
neonatal intensive care units in Colombia, infants born prematurely, with a
birth weight of 2000 grams or smaller, were randomized to two groups, one that
was given five drops daily of Lactobacillus reuteri Protectis (BioGaia
ProTectis, n=372) and one that was given a corresponding placebo (n=378).
The study was published online in Pediatrics on 15 October
2012 (http://pediatrics.aappublications.org/content/early/2012/10/10/peds.2011
-3584.abstract).
Necrotizing enterocolitis – a fatal disease
NEC is the death of intestinal tissue. It predominantly affects premature
infants and often results in death or serious medical or neurodevelopmental
complications, such as cerebral palsy (CP) and cognitive, visual or hearing
impairment. The rate of NEC is highest in the smallest neonates (< 1500 grams)
where around 10% of the infants are infected. The death rate ranges between 20
and 30%, with the highest rate among infants requiring surgery.
Lactobacillus reuteri – a well researched probiotic
Lactobacillus reuteri is one of the world's most well researched probiotics,
especially in young children. To date 92 clinical studies using BioGaia's human
strains of Lactobacillus reuteri have been performed in more than 7,700
individuals of all ages. Half of the studies have been performed in premature
babies, infants and children. Results are published in 63 articles in scientific
journals (September 2012).
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BioGaia has published this information in accordance with the Swedish Securities
Market Act. The information was issued for publication on 15 October 2012, 15:30
am CET.
For additional information please contact
Peter Rothschild, President, BioGaia: +46 8 555 293 00
Mario A. Rojas, Dr, Department of Pediatrics, Wake Forest School of Medicine:
mrojas@wakehealth.edu
Eamonn Connolly, Senior Vice President Research, BioGaia: +46 8 555 293 00
BioGaia is a healthcare company that develops, markets and sells probiotic
products with documented health benefits. The products are primarily based on
the lactic acid bacterium Lactobacillus reuteri, which has probiotic, health
-enhancing effects. The class B share of the Parent Company BioGaia AB is quoted
on the Mid Cap list of the NASDAQ OMX Nordic Exchange Stockholm. www.biogaia.com
