Therapeutic use of human milk IgA in newborns submitted to gastroschisis corrective surgery

Abstract

Neonatal period-related diseases and congenital malformations represent nowadays the main components of infantile mortality in the State of São Paulo (11.4/1,000 live births in 2014). Infection constitutes the main cause of death among neonates, not only due to immunological immaturity that characterizes this age group but also to clinical and surgical therapeutic manipulations required for adequate treatments. In order to compensate for this immaturity, nature provides newborn with maternal antibodies through IgG placental transfer and with colostrum and milk secretory IgA (SIgA). In this work, we intend to obtain SIgA preparations from human colostrum and milk by two methods: i. through a purification process that was developed and patented by the own project proponents. In this process, purified SIgA has its biochemical integrity and biological antibody activities preserved, especially against enteric bacteria; ii. the liquid phase of human colostrum and milk will be obtained, free of fats and cells, which maintains IgA and other soluble bioactive factors of the milk. This first study with the SIgA preparations, administered orally as a food supplement, focuses on its therapeutic capacity for protecting newborns with gastroschisis (a congenital malformation of abdominal wall) from infections, which, in most cases, are caused by intestinal bacteria, and represent the main causes of morbidity and mortality in affected neonates during postsurgical period.Other groups of patients in the future may also benefit from such preparations of SIgA, which have no similar available, such as: i. very low birth weight premature infants, unable to suckle; ii) immunosuppressed children and adults due to neoplasias and other conditions that require immunosuppressive medications, especially organ and tissue transplants. For such conditions, depending on risks and complications, SIgA could be administered both orally and via the nasal route. This study opens perspectives for the formation of a startup, with a great incentive from the HC-FMUSP Innovation Center to develop new products. (AU)