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• W2979128919 abstract "Purpose: The use of pancreatic enzyme products to correct exocrine pancreatic insufficiency (EPI) in CF patients is critical to avoid malnutrition. Oral caloric intake may be supplemented by gastrostomy tube (G-tube) feedings. The formula in the feeding bag has been traditionally mixed with a pancreatic enzyme powder, which results in a predigested formula of high osmolarity that can lead to frequent defecation and precipitated proteins in the formula that may clog the G-tube. PANCRECARB® MS-4, an enteric-coated, buffered enzyme product, contains microspheres small enough to traverse the G-tube. The goal of this single center, open label, prospective, crossover study was to establish the safety and efficacy of PANCRECARB® MS-4 delivered by G-tube in CF Patients. Methods: The study consisted of two phases, each of which lasted for thirty days. Subjects received a high-fat diet with optimized doses of oral enzymes throughout the study. Phase I subjects were supplemented with nocturnal GT feedings mixed with a pancreatic enzyme powder. Phase II subjects received PANCRECARB® MS-4 at a 50% reduced lipase dose via G-tube during the nocturnal feedings. During the last 3 days of Phase I and II, subjects were admitted to a controlled environment for clinical evaluation and stool collection. Results: Six subjects completed the study [mean age 7.9 yrs]. For the PANCRECARB® MS-4 phase, mean lipase dose decreased by 50.5% [9128 to 4490 U/kg/day] [p=0.006], mean CFA increased by 2.6% and mean weight gain was 0.5 kg as compared to pancreatic enzyme powder phase. Conclusion: G-tube administration of a 50% reduced lipase dose of PANCRECARB® MS-4 during nocturnal feedings was as effective as a higher dose of a pancreatic enzyme powder mixed with the formula. No adverse effects of PANCRECARB® MS-4 administration by G-tube were encountered. This work was funded by Digestive Care Inc., Bethlehem, PA. Disclosure: Dr WS Warren, Consultant, Digestive Care, Inc., Bethlehem, PA, USA." @default.
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• W2979128919 date "2009-10-01" @default.
• W2979128919 modified "2023-09-26" @default.
• W2979128919 title "Evaluation of an Enteric-Coated Buffered Pancreatic Enzyme Product in Cystic Fibrosis Patients with Gastrostomy Tubes" @default.
• W2979128919 doi "https://doi.org/10.14309/00000434-200910003-00176" @default.
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