Oral therapy of necrotizing enterocolitis
View Patent ↗The present invention relates to methods of treating or reducing the risk of necrotizing enterocolitis (NEC) in an infant comprising orally administering an effective amount of a CpG-ODN. It is based, at least in part, on the results of experiments in which orally administered CpG-ODNs were observed to reduce the histopathology and markers of inflammation in a murine model for NEC. The present invention further provides for oral formulations of CpG-ODN for administration to infants.
1. An infant nutritional formula comprising a therapeutically effective amount of a CpG-ODN comprising 5′ TCGTCGTTTTGTCGTTCCTGACGTT 3′ (SEQ ID NO:9), further comprising nutrients selected from the group consisting of proteins, lipids, carbohydrates, electrolytes, and vitamins.
2. The infant nutritional formula of claim 1 , where the formula is nutritionally complete.
3. The infant nutritional formula of claim 1 , where the concentration of CpG-ODN provides a daily dose of between about 0.1-10 mg/kg.
4. The infant nutritional formula of claim 3 where the daily dose provided is about 1 mg/kg.
5. The infant nutritional formula of claim 1 , where the CpG-ODN is comprised in a particle selected from the group consisting of a micelle, liposome, microsphere or nanoparticle.
6. The infant nutritional formula of claim 1 , wherein the CpG-ODN comprises one or more phosphorothioate linkage.