Necrotizing enterocolitis (NEC) is a debilitating disease that affects preterm infants, occurring in about 7% of very low birth weight infants. NEC has a mortality rate of over 20%, and infants who recover experience lifelong complications. The treatment of a single NEC patient can cost over $1 million dollars and collectively costs the US health system more than $5 billion/year. The exact cause of NEC remains unknown, and the only effective preventative therapy is maternal milk provided either from the mother or, increasingly, from donor milk banks. Studies have shown that maternal milk reduces the incidence of NEC by half. Preliminary data derived from both premature infant fecal samples and pre-clinical data on a mouse model indicates that maternal Immunoglobulin A (IgA), an antibody that is secreted in large amounts in breast milk, is critical to the protective effect. IgA may provide the key to minimizing or eliminating the harmful impacts and costs of this disease.
Description
Bacteria that escapes binding by maternal antibodies such as IgA has been associated with later development of NEC. We have developed a bacterial array which allows for determination of the anti-bacterial repertoire--the number of different bacteria that can be bound--of any given breast milk sample. The breadth of IgA specificity for these bacteria as determined by the array will indicate which milk samples are the most effective at preventing NEC, and will allow NICU doctors and donor milk banks to target milk samples to the most at-risk infants. The array is both customizable to customer needs and fast to run with a 24 hour turn-around time. The array can also be repurposed to combat other infant health risks, such as bacteremia and viremia.
Applications
· Prevention of necrotizing enterocolitis in infants
· Preventing bacteremia, early life enteric viral infection, and other conditions that arise from low antibody specificity
Advantages
· Treatment of NEC with natural breast milk from the mother or donor
· Measures responses against surface antigens, alleviating false positive occurrences associated with bacterial lysate arrays.
· Does not require immunization
· Inexpensive, fast, non-invasive and customizable test
· No modification of breast milk is necessary
Invention Readiness
Device designed
Proof of principle in place
Post-hoc clinical trial pending
IP Status
https://patents.google.com/patent/US20210332113A1
