10
Participants
Start Date
August 31, 2018
Primary Completion Date
May 31, 2019
Study Completion Date
September 30, 2019
GlycosBio Nutritional Supplement + PERT placebo
"The lipid (fat) in the GlycosBio Nutritional Supplement (GBNS) was provided in the form of a re-structured lipid monoacylglyceride (MAG) produced by the study sponsor. MAGs are readily absorbed by enterocytes without the need of digestion by pancreatic lipases. The MAG oil is produced enzymatically from almond oil. The product also contains essential amino acids, carbohydrates as simple sugars and fat-soluble vitamins and minerals. The GBNS to be administered in a volume sufficient to supply 0.5 g of MAG per kg of body weight"
Standard Nutritional Supplement + PERT
A 5.9% fat triacylglycerol-based commercially available nutritional supplement (Boost Plus®, Nestlé Health Science, Bridgewater, NJ) in a volume sufficient to supply 0.5 g of TAG per kg of body weight over the same time period and PERT capsules (24,000 iu/capsule) at a dose of 2,500 iu of lipase activity per gram of fat ingested.
Clinical Research Center (CRC) at Texas Children's Hospital, Houston
Baylor College of Medicine
OTHER
GlycosBio, Inc.
INDUSTRY