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Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients

NCT06691893 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-15

No results posted yet for this study

Summary

This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, a painful inflammation of the pancreas. EPI occurs when the pancreas does not produce enough enzymes to help the body properly digest food. While pancreatic enzyme replacement therapy (PERT) is commonly used to manage EPI symptoms, it can be challenging for people who rely on feeding tubes. RELiZORB, could help these patients by simplifying the delivery of the enzymes they need. However, RELiZORB has only been studied in people with EPI caused by cystic fibrosis, so its effectiveness in pancreatitis patients remains unknown. This study aims to determine whether RELiZORB is effective for individuals requiring feeding tube support after pancreatitis.

Conditions

Interventions

DEVICE

RELiZORB

RELiZORB (immobilized lipase) is a therapeutic device designed to enhance fat absorption in patients receiving enteral tube feedings. It works by hydrolyzing fats found in enteral formulas. RELiZORB is a single-use cartridge that connects in-line with enteral feeding sets. It contains lipase covalently bound to small polymer beads, forming a complex called iLipase, which remains within the cartridge. As the enteral formula passes through the cartridge, its fat content is hydrolyzed upon contact with iLipase. This process is especially beneficial for the absorption of long-chain polyunsaturated fatty acids, which require hydrolysis by pancreatic lipase for proper intestinal absorption. RELiZORB is compatible with a wide variety of commercially available enteral formulas.

Sponsors & Collaborators

Principal Investigators

  • Casey M Luckhurst, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2027-04-15
Completion
2027-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06691893 on ClinicalTrials.gov