Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Completed · Not applicable · Has a placebo group

Conditions studied: Exocrine Pancreatic Insufficiency

In brief

Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.

Key facts

Study ID

NCT02598128

Run by

Alcresta Therapeutics, Inc.

People needed

34

Starts

2015-11-01

Expected to finish

2016-06-01

Last updated by the study team

2017-01-25

Who can join

Age: 4 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed CF diagnosis with 2 clinical features
• Documented history of EPI
• Enteral formula use minimum of 4x/week
• Written informed consent or assent, as applicable

You may not qualify if…

• Uncontrolled diabetes mellitus
• Signs and symptoms of liver cirrhosis or portal hypertension
• Lung/liver transplant
• Active cancer currently receiving cancer treatment
• Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
• DIOS or fibrosing colonopathy

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• St. Luke's Cystic Fibrosis Center of Idaho — Boise, Idaho, United States
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Monroe Carell Junior Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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