Recruiting
Phase 3

RELiZORB

Sponsor:

Massachusetts General Hospital

Code:

NCT06691893

Conditions

Exocrine Pancreatic Insufficiency (EPI)

Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RELiZORB

Study Details

Brief 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

Exocrine Pancreatic Insufficiency (EPI)

Pancreatitis

Study ID

NCT06691893

Start date

Mar 28, 2025

Status verified date

May, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient diagnosed with moderate or severe exocrine pancreatic insufficiency (EPI), as defined using the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) symptom score of 1.4 or greater.
  • Patient diagnosed with acute, recurrent acute pancreatitis or subacute pancreatitis. Subacute pancreatitis is defined as recent diagnosis of acute pancreatitis with sequelae of the acute episode including infection, pseudocyst, walled-off pancreatic necrosis.
  • Patient is currently admitted to the hospital at the time of study enrollment.
  • Patient requiring at least 50% of daily caloric and fluid intake through enteral tube feeds.
  • Patient is able and willing to provide informed consent.

Exclusion Criteria:

  • Patient with chronic pancreatitis
  • Patient is currently intubated and unable to provide consent
  • Patient with active gastrointestinal tract cancer
  • Patient requiring less than 50% of nutritional support at time of enrollment
  • Patient is unable to tolerate any form of enteral nutrition

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Casey M Luckhurst, MD

617-726-2760cluckhurst@mgb.org

Yasmin G Hernandez-Barco, MD

yhernandez-barco@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Casey M Luckhurst, MD

617-726-2760cluckhurst@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • exocrine pancreatic insufficiency
  • pancreatitis
  • RELiZORB
  • lipase
  • enteral nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-15.