Safety and Efficacy of a Novel Microbial Lipase in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis: A Randomized Controlled Clinical Trial

Heubi, James E.; Schaeffer, David F.; Ahrens, Richard C.; Sollo, Natalie; Strausbaugh, Steven; Graff, Gavin R.; Jain, Raksha; Witte, Stephan; Forssmann, Kristin

doi:10.1016/j.jpeds.2016.05.049

Cited by 19 publications

(21 citation statements)

References 16 publications

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“…A recent randomized crossover trial of a novel liquid microbial lipase (NM-BL) formulation showed efficacy for the treatment of PI in CF patients [73]. This was an early phase trial; therefore, a larger phase III study will be required before this is available for patients.…”

Section: Novel Therapiesmentioning

confidence: 99%

Pancreatic insufficiency in Cystic Fibrosis

Singh

Schwarzenberg

2017

Journal of Cystic Fibrosis

148

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Section: Novel Therapiesmentioning

confidence: 99%

Pancreatic insufficiency in Cystic Fibrosis

Singh

Schwarzenberg

2017

Journal of Cystic Fibrosis

148

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“…Enzyme products are a combination of all digestive enzymes and other components derived from porcine pancreas. There are non-capsule enzyme options to treat fat malabsorption, such as an immobilized lipase-only containing device available for use with enteral tube feeding (RELiZORB1 Alcresta Therapeutics, Inc, Newton, Massachusetts, USA) [33], a bacterial-derived lipase-only product suspended in a liquid solution for use with meals (Burlulipase, Nordmark Arzneimittel, Uetersen, DE) [34] and a non-enteric coated enzyme powder (Viokase, Axcan Pharma US, Inc., Mont-saint-hilaire, Quebec, CA). Although lipase containing drugs improve triglyceride digestion in lipase-limited diseases, Encala™ is the only non-enzyme approach and has demonstrated improved fat absorption, growth, and nutritional status when used in conjunction with PERT.…”

Section: Plos Onementioning

confidence: 99%

Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial

et al. 2020

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Background In the primary analysis of a 12-month double-blind randomized active placebo-controlled trial, treatment of children with cystic fibrosis (CF) and pancreatic insufficiency (PI) with a readily absorbable structured lipid (Encala™, Envara Health, Wayne, PA) was safe, well-tolerated and improved dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA). Objective To determine if the Encala™ treatment effect varied by severity of baseline fat malabsorption. Methods Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a threemonth treatment with Encala™ or a calorie and macronutrient-matched placebo were included in this subgroup analysis. Subjects were categorized by median baseline CFA: low CFA (<88%) and high CFA (�88%). At baseline and 3-month evaluations, CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores were calculated. Fasting plasma fatty acid (FA) concentrations were also measured. Results Subjects in the low CFA subgroup had significantly improved CFA (+7.5±7.2%, mean 86.3 ±6.7, p = 0.002), and reduced stool fat loss (-5.7±7.2 g/24 hours) following three months of Encala TM treatment. These subjects also had increased plasma linoleic acid (+20%), α-linolenic acid (+56%), and total FA (+20%) (p�0.005 for all) concentrations and improvements in HAZ (0.06±0.08), WAZ (0.17±0.16), and BMIZ (0.20±0.25) (p�0.002 for all). CFA and FA

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“…The transesterification of sn-1,3-specific lipase-catalyzed oil and triglyceride with high content of sn-2 unsaturated fatty acids can reduce oil saturation and increase the level of unsaturated fatty acids [47]. These kinds of lipase are mostly found in microorganisms, such as Aspergillus niger, Rhizopus delemar, Mucor miehei, and Humicola lanuginosa [48]. Lipases can be used to catalyze the resolution of optical isomers and the synthesis of chiral compounds due to their stereospecificity, which is a research hotspot in the field of enzyme engineering [49].…”

Section: Lipasementioning

confidence: 99%

Enzymatic Synthesis of Functional Structured Lipids from Glycerol and Naturally Phenolic Antioxidants

Wang¹,

Zhu²,

Wang³

et al. 2019

Glycerine Production and Transformation - An Innovative Platform for Sustainable Biorefinery and Energy

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Glycerol is a valuable by-product in biodiesel production by transesterification, hydrolysis reaction, and soap manufacturing by saponification. The conversion of glycerol into value-added products has attracted growing interest due to the dramatic growth of the biodiesel industry in recent years. Especially, phenolic structured lipids have been widely studied due to their influence on food quality, which have antioxidant properties for the lipid food preservation. Actually, they are triacylglycerols that have been modified with phenolic acids to change their positional distribution in glycerol backbone by enzymatically catalyzed reactions. Due to lipases' fatty acid selectivity and regiospecificity, lipase-catalyzed reactions have been promoted for offering the advantage of greater control over the positional distribution of fatty acids in glycerol backbone. Moreover, microreactors were applied in a wide range of enzymatic applications. Nowadays, phenolic structured lipids have attracted attention for their applications in cosmetic, pharmaceutical, and food industries, which definitely provide attributes that consumers will find valuable. Therefore, it is important that further research be conducted that will allow for better understanding and more control over the various esterification/ transesterification processes and reduction in costs associated with large-scale production of the bioconversion of glycerol. The investigated approach is a promising and environmentally safe route for value-added products from glycerol.

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Safety and Efficacy of a Novel Microbial Lipase in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis: A Randomized Controlled Clinical Trial

Cited by 19 publications

References 16 publications

Pancreatic insufficiency in Cystic Fibrosis

Pancreatic insufficiency in Cystic Fibrosis

Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial

Enzymatic Synthesis of Functional Structured Lipids from Glycerol and Naturally Phenolic Antioxidants

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