Skip to main content
OpenTrials
Completed

NCT Number: NCT02598128

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exocrine Pancreatic Insufficiency Digestive System Diseases Pancreatic Diseases

Age range

4 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RELiZORB

Device

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.

Other names: Peptamen 1.5, Impact Peptide 1.5

PLACEBO

Device

Sham device

Primary outcomes

  1. Number of Patients With Adverse Events and Unanticipated Adverse Device Effects

    Time frame: 27 days

    • Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)

  2. Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)

    Time frame: Day 1 first intervention and Day 9 second intervention.

    AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours

Other outcomes

  1. Ease of Use of RELiZORB (Per-Protocol Population)

    Time frame: Period C: Single assessment on Day 19 or 20

    Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other.

Sponsors and collaborators

Lead sponsor

Alcresta Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2015
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.