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Evaluating RELiZORB for Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients

This study is looking at how well a device called RELiZORB works for people with exocrine pancreatic insufficiency (EPI) who are fed through a tube. EPI happens when your pancreas doesn't make enough enzymes to digest food, often after pancreatitis (inflammation of the pancreas). RELiZORB is a single-use cartridge that connects to your feeding tube and helps break down fats in your tube feeding. It has been studied in other conditions, but its effectiveness for EPI caused by pancreatitis is unknown. The study aims to enroll 60 adults, aged 18 and older, who have moderate to severe EPI and have experienced acute, recurrent acute, or subacute pancreatitis. Success will be measured by changes in your EPI symptoms using a questionnaire after 14 days.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 14 days from randomization.

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NCT06691893

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Massachusetts General Hospital
~60 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:RELiZORB

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)
Measured over Measured at 14 days from randomization

Conditions

Exocrine Pancreatic Insufficiency (EPI)
Pancreatitis

Explore related trials

Pancreatic InsufficiencyPancreatitis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Casey M Luckhurst, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Casey M Luckhurst, MD
[email protected]
617-726-2760
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)Measured at 14 days from randomization

    The PEI-Q is an 18-item Patient-Reported Outcome (PRO) questionnaire designed to help individuals with pancreatic exocrine insufficiency (PEI) assess their symptoms and the impact on their health-related quality of life. Created and validated by Adelphi Values UK in collaboration with Abbott, the PEI-Q is available for use in clinical studies without the need to purchase a license. The scoring system ranges from 0 to 4, with higher scores indicating more severe symptoms. A score between 0.6 and 1.4 reflects mild PEI, 1.4 to 1.8 indicates moderate PEI, and a score of 1.8 or higher signifies severe or poorly controlled PEI. Our primary outcome measure is examining the change in baseline PEI-Q symptom score.