Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

May 31, 2019

Study Completion Date

September 30, 2019

Conditions
Cystic FibrosisExocrine Pancreatic Insufficiency
Interventions
DIETARY_SUPPLEMENT

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"

DIETARY_SUPPLEMENT

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.

Trial Locations (1)

77030

Clinical Research Center (CRC) at Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

lead

GlycosBio, Inc.

INDUSTRY

NCT04966897 - Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis | Biotech Hunter | Biotech Hunter