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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06691893
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RELiZORB — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 28, 2025
Status verified
May 2026
Primary completion
Apr 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: No RELiZORB
    Patients will receive tube feeds (via nasogastric or nasojejunal tube) without the use of RELiZORB
  • Experimental: RELiZORB
    Patients will receive tube feeds (via nasogastric or nasojejunal tube) with the use of RELiZORB

Primary Outcome Measure

Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) [ Time Frame: Measured at 14 days from randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Casey M Luckhurst, MD
[email protected]
617-726-2760

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies