Evaluating RELiZORB for managing pancreatic enzyme insufficiency in tube-fed patients
A Randomized Controlled Trial to Evaluate the Efficacy of Immobilized Lipase (RELiZORB) During Enteral Nutrition in Patients With Exocrine Pancreatic Insufficiency Secondary to Acute Pancreatitis
This study is testing if RELiZORB can help tube-fed patients with pancreatic enzyme insufficiency digest food better while they are in the hospital.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06691893 on ClinicalTrials.gov |
What this trial studies
This research aims to assess the effectiveness of RELiZORB in managing exocrine pancreatic insufficiency (EPI) in patients who are tube-fed due to pancreatitis. EPI can occur after pancreatitis when the pancreas fails to produce sufficient enzymes for digestion. The study will involve patients diagnosed with moderate to severe EPI who require enteral nutrition and are currently hospitalized. By simplifying enzyme delivery, RELiZORB may improve patient compliance and nutritional outcomes, addressing a significant gap in current treatment options for tube-fed patients with EPI.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients diagnosed with moderate or severe EPI who require at least 50% of their caloric intake through enteral tube feeds.
Not a fit: Patients with chronic pancreatitis or those who do not require tube feeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a more effective and practical solution for managing EPI in tube-fed patients, improving their nutritional status and quality of life.
How similar studies have performed: While RELiZORB has shown effectiveness in cystic fibrosis patients, its application in pancreatitis patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Casey M Luckhurst, MD — Massachusetts General Hospital
- Study coordinator: Casey M Luckhurst, MD
- Email: cluckhurst@mgb.org
- Phone: 617-726-2760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.