Very low birth-weight infants assigned to receive lactoferrin supplements, alone or with Lactobacillus rhamnosus GG (LGG), could reduce the incidence of late-onset sepsis by over 12 per cent, according to results of a randomised trial from Italy.
“Infections are the most common cause of death in premature infants and a major threat for poor outcomes,” wrote the authors in the Journal of the American Medical Association. Late-onset sepsis, or infections that arise around the time of the birth, mainly occur in the hospital and are said to affect about 20 per cent of very low birth-weight babies, said the authors.
The study found that the incidence of late-onset sepsis in the infants supplemented with lactoferrin from cow’s milk was 5.9 per cent, while the incidence in infants receiving lactoferrin plus LGG was 4.6 per cent. On the other hand, 17.3 per cent of the infants in the placebo group developed an infection, said the researchers, led by Paolo Manzoni of S. Anna Hospital in Torino.
“Prevention of neonatal sepsis relies on hygiene measures, cautious use of invasive procedures, medication stewardship, administration of fresh maternal milk, and early diagnosis,” wrote Manzoni and his co-workers.
“Nevertheless, none of these interventions is fully effective in decreasing the burden of the disease and overall have not been subjected to randomized controlled trials.
“This study has demonstrated that supplemental bovine lactoferrin, either alone or in combination with LGG, reduces first episodes of late-onset sepsis in very-low birth weight infants,” they added.
Lactoferrin that is an important component of human breast milk has struggled to communicate its immune system-boosting health benefits to the public and compete against other commodity protein fractions such as whey which sell at a fraction of the price of lactoferrin.
Estimates put the global market for the ingredient that counts Japan and South Korea among its biggest markets at little more than €20m.
In those markets it is popular in milk drinks and food supplements but health claims are rarely made - products simply flag the presence of lactoferrin.
The researchers included 472 very low birth weight infants, meaning a birth weight less than 1.5 kg (3.3 lbs). The infants were randomly assigned to one of three groups, one received the lactoferrin (100 mg/d, LF100 by Dicofarm SpA), one received lactoferrin (100 mg/d) plus LGG (6 billion cfu/d, Dicofarm SpA), and the third received a placebo for the first 30 days of their lives.
The decrease in the incidence of late-onset sepsis was observed for both bacterial and fungal sepsis, said the researchers. Furthermore, the risk of death attributable to sepsis was significantly lower in the two groups, added the researchers. Importantly, no adverse effects were recorded.
“Given the high homology between human lactoferrin and bovine lactoferrin, it might be argued that supplemented bovine lactoferrin overlaps with maternal milk in protecting against sepsis,” said the researchers.
“However, in untreated infants the incidence rates of late-onset sepsis were similar in those fed exclusively maternal milk versus exclusively formula; furthermore, the decrease in late-onset sepsis episodes in treated infants was comparable regardless of the type of milk feeding.
“Thus, maternal milk alone does not confer the benefits of bovine lactoferrin supplementation. This implies the need for additional lactoferrin, specifically to prevent late-onset sepsis,” they added.
Source: Journal of the American Medical Association
Volume 302, Issue 13, Pages 1421-1428
“Association for Research in Otolaryngology's annual conference in BaltimoreBovine Lactoferrin Supplementation for Prevention of Late-Onset Sepsis in Very Low-Birth-Weight Neonates: A Randomized Trial”
Authors: P. Manzoni, M. Rinaldi, S. Cattani, L. Pugni, M.G. Romeo, et al.