361 - Immobilized lipase cartridge (ILC) increases delivery of hydrolyzed fats in pasteurized donor human milk (PDHM) during tube feeding

Publication Number: 3348.361

Greta Loring, Alcresta Therapeutics, Waltham, MA, United States; Craig Fairchild, Alcresta Therapeutics, Inc., Waltham, MA, United States; Stephen J. Davia, Alcresta Therapeutics, Inc., Dorchester, MA, United States; Lisa M. Stellwagen, University of California, San Diego School of Medicine, LA JOLLA, CA, United States; Michael M.. Yeh, Alcresta Therapeutics, Waltham, MA, United States

Background: Human milk remains the gold standard for infant nutrition, particularly in preterm populations. When mother's own milk (MOM) is unavailable, pasteurized donor human milk (PDHM) is the preferred alternative. However, the standard milk banking pasteurization process inactivates bile salt-stimulated lipase (BSSL) in human milk, which may impair fat digestion and absorption, especially in preterm infants with immature pancreatic function.

Fat malabsorption in this population can present as feeding intolerance and compromise both overall nutritional status and the uptake of essential fatty acids critical for neurodevelopment and growth.

To improve fat digestion, the immobilized lipase cartridge or ILC (RELiZORB®) is FDA-cleared for pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding. Integrated into the feeding line, the ILC hydrolyzes triglycerides, delivering absorbable fatty acids directly to the gastrointestinal tract to support optimal nutrient utilization. However, its utility in hydrolyzing fats in PDHM has not been established.

Objective: To evaluate the compatibility of the ILC with PDHM, with and without nutrient fortification, for enteral feeding in neonates and infants.

Design/Methods: Pasteurized donor human milk (PDHM; 20 kcal/oz; not available for clinical use) from the UC Health Milk Bank, either alone or fortified to 24 kcal/oz with human milk fortifier or infant formula, was evaluated using the ILC in simulated enteral feeding scenarios. As shown in Figure 1, the ILC was connected to an offset enteral syringe and patient extension set installed in a syringe pump positioned at a 45º angle to optimize fat delivery. Hydrolyzed PDHM was collected after passing through the ILC and analyzed for free fatty acids to assess fat digestion. Due to the physiologic lipase activity in raw human milk that occurs prior to pasteurization, baseline hydrolysis was measured for the PDHM lots tested. Results include both baseline and total fat hydrolysis (baseline + ILC-mediated hydrolysis).

Results: Table 1 summarizes simulated use results. Baseline fat hydrolysis ranged from 19-35% across 8 pasteurized human milk lots. The ILC significantly increased hydrolyzed fat content in both unfortified and fortified PDHM. Extended residence time within the ILC enhanced fat hydrolysis in some scenarios.

Conclusion(s): The ILC hydrolyzes triglycerides in both fortified and unfortified PDHM, increasing enteral delivery of absorbable fats to neonates and infants. This approach offers the potential for improved feeding tolerance, optimize fat absorption, and support growth.

Figure 1. Immobilized lipase cartridge installation in enteral feeding circuit for simulated use testing with pasteurized donor human milk (PDHM)
A) The Immobilized lipase cartridge (ILC) consists of a clear cartridge body with an orange cap that contains an immobilized lipase enzyme on small beads that are contained within the cartridge by filters on either end of the cartridge. B) The ILC connects to ENFit compatible tube feeding supplies. A syringe filled with PDHM is connected to the inlet of the ILC and a patient extension set is connected to the orange outlet of the ILC. C) The syringe-ILC-extension set assembly was installed in a syringe pump for controlled flow rate delivery at 40, 120 and 400 mL/hr. The pump was positioned at a 45º angle to facilitate delivery of fat during the simulated tube feeding.

Table 1. Immobilized lipase cartridge hydrolyzes triglyceride fats in pasteurized donor human milk (PDHM)
Pasteurized donor human milk (PDHM, 250 mL) with and without nutrient fortification was evaluated for use with the immobilized lipase cartridge (ILC) at 40, 120 and 400 mL/hr. The caloric density, fat content and fat hydrolysis data, both baseline and with the ILC are shown in Table 1.