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

Study Overview
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Brief Summary
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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.

Detailed Description
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Protocol ALCT-0000497 consists of three distinct study periods as follows: In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home. 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. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.

Official Title
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Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding In-line Digestive Enzyme Cartridge (RELIZORB) in Patients With Cystic Fibrosis Receiving Enteral Feeding

Conditions
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Exocrine Pancreatic Insufficiency

Intervention / Treatment
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* Device: RELiZORB
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RELiZORB<br>Treatment (RELiZORB) | Device: RELiZORB<br>* Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.<br>* Other names: Impact Peptide 1.5;|
| Placebo Comparator: Control<br>Placebo control | Device: Placebo<br>* Sham device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events and Unanticipated Adverse Device Effects | 1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE) | 27 days | 
| Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population) | AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours | Day 1 first intervention and Day 9 second intervention. |