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

Alcresta

Status: Completed

Conditions: Exocrine Pancreatic Insufficiency

Treatments: Device: Placebo; Device: RELiZORB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598128

ALCT-0000497

Details and patient eligibility

About

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.

Full description

Protocol ALCT-0000497 consists of three distinct study periods as follows:

1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.
2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.
3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.

Enrollment: 34 patients

Sex: All

Ages: 4 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

RELiZORB

Experimental group

Description:

Treatment (RELiZORB)

Treatment:

Device: RELiZORB

Control

Placebo Comparator group

Description:

Placebo control

Treatment:

Device: Placebo