A retrospective sequential analysis of 311 premature infants, born with a weight below 1,000 grams, showed that prophylactic supplementation of Lactobacillus reuteri Protectis resulted in a statistically significant reduction in necrotizing enterocolitis (NEC), the most common gastrointestinal cause of death and illness in premature infants. NEC has a death rate of 20 percent to 30 percent.
Since the introduction of preventive supplementation of Lactobacillus reuteri Protectis to all premature infants in the neonatal intensive care unit where the study was performed, one case of NEC was avoided for every eight infants treated.
“In light of these benefits and no signs of toxicity, early initiation of BioGaia ProTectis is a standard of practice in our neonatal intensive care unit which has continued to prevent NEC in our neonates below 1,000 grams birth weight for 1.5 years past completion of the study,” says Dr Mary Ann VT Dimaguila, Neonatologist, Piedmont Neonatology, PC and Women’s Hospital of Greensboro, North Carolina, USA.
In the retrospective cohort sequential analysis, medical records for 311 premature infants were reviewed, 232 in the years before introduction of Lactobacillus reuteri Protectis prophylaxis (January 2004 - June 2009) and 79 who received Lactobacillus reuteri Protectis prophylaxis (June 2009 - April 2011).
The review compared the rates of NEC in premature infants ≤ 1,000 grams birth weight. The incidence of NEC was significantly lower in the infants who received Lactobacillus reuteri Protectis, two of 79 infants (2.5 percent) compared to 35 of 232 (15.1 percent) of the untreated infants (p=0.0475). No adverse events related to the use of Lactobacillus reuteri Protectis were noted. The preventive supplementation of Lactobacillus reuteri Protectis resulted in avoidance of one case of NEC for every eight infants treated (NNT=8).
The study was published online in the journal BMC Pediatrics on 4 September 2012.
“It is very encouraging to see that Lactobacillus reuteri is reducing suffering and saving lives in neonates and that gives us reason for continued studies in this interesting and sensitive area,” says Peter Rothschild, CEO of BioGaia.
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 (< 1,500 grams) where around 10 percent of the infants are infected. The death rate ranges between 20 and 30 percent, with the highest rate among infants requiring surgery.