Clinical Trials of Lactoferrin in the Newborn: Effects on Infection and the Gut Microbiome

Newborn infants, and especially those born preterm, are at risk of infections in early life. In preterm infants, necrotising enterocolitis (NEC), a devastating inflammatory gut condition, and late onset sepsis (LOS) are important causes of serious morbidity and are the commonest reason for death after the first week of life.

Considerable effort has been expended to better understand which specific components of human milk are likely to exert the greatest functional benefits, particularly those that have immune modulatory or ‘anti-infectious’ properties. Lactoferrin is a whey glycoprotein present in especially high concentrations in colostrum and early milk. Studies show that lactoferrin impacts on immune function and, through a multitude of mechanisms, reduces the risk of viral, fungal and bacterial infections.

However, the largest trial to date - the Enteral Lactoferrin in Neonates trial (ELFIN) - recruited 2203 infants and failed to show any significant reductions in LOS or NEC. Challenges in conducting clinical research and the translational relevance of these studies for clinical practice will be considered.