The Current Treatment Practice Cannot Adequately Address Fat Malabsorption
In this study, DHA and EPA plasma concentrations were approximately 60% of values observed in normal subjects.1
Before participating in a multicenter, randomized, double-blind, crossover trial with an open-label safety evaluation period, patients had been receiving up to 1.5 L of enteral formula overnight for a mean of 6.6 years, and yet...*1
Still had plasma concentrations of omega-3 fatty acids that were well below concentrations found in healthy humans1
Had BMI or BMI percentiles that were below target for patients with CF1
These suboptimal nutrition measurements occurred despite use of a mean of 8 to 9 pancreatic enzyme replacement therapy (PERT) capsules in conjunction with enteral nutrition1
In enteral formulas, protein can be prepared in a form that is pre-hydrolyzed, stable, and available to be readily absorbed. However, pre-hydrolyzed fatty acids and monoglycerides are not available in enteral formulas since they are not stable and spoil quickly.
PERT Capsules Are Not Formulated to Be Added to Enteral Feeding Systems
PERT capsules are indicated for oral use and are not intended to be crushed or added to enteral feeding regimens2
Enteric-coated microspheres may separate from meal contents in the stomach and not adequately mix during delivery to the small intestine3
Some unprotected enzymes may fail due to prolonged exposure to gastric acid4
Even when PERT capsules are administered in large doses, there have been no results of complete restoration of normal fat absorption3
PERT capsules were not designed to work with enteral formula and have been shown to result in...
Clogged feeding tubes5
Activity that peaks after 30 minutes and wanes over the next 2 hours2,5
Only a small number of patients experiencing normalization of fat malabsorption, with many requiring individualized therapy3
Current practices using PERT capsules with enteral nutrition have not been adequately studied for use in hydrolyzing key fats in enteral nutrition.6
*This study was funded by Alcresta Therapeutics, Inc., and conducted among patients with cystic fibrosis.
Freedman S, Orenstein D, Black P, et al. Increased fat absorption from enteral formula through an in-line digestive cartridge in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2017;65(1):97-101.
Berry AJ. Pancreatic enzyme replacement therapy during pancreatic insufficiency. Nutr Clin Pract. 2014;29(3):312-321.
Trang T, Chan J, Graham DY. Pancreatic enzyme replacement therapy for pancreatic exocrine insufficiency in the 21st century. World J Gastroenterol. 2014;20(33):11467-11485.
Kalnins D, Wilschanski M. Maintenance of nutritional status in patients with cystic fibrosis: new and emerging therapies. Drug Des Devel Ther. 2012;6:151-161.
Ferrie S, Graham C, Hoyle M. Pancreatic enzyme supplementation for patients receiving enteral feeds. Nutr Clin Pract. 2011;26(3):349-351.
Schwarzenberg SJ, Hempstead SE, McDonald CM, et al. Enteral tube feeding for individuals with cystic fibrosis: Cystic Fibrosis Foundation evidence-informed guidelines. J Cyst Fibros. 2016;15(6):724-735.