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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a product called RELiZORB, which may help patients with exocrine pancreatic insufficiency (EPI) who are being fed through a tube after experiencing pancreatitis. EPI happens when the pancreas doesn’t make enough enzymes needed to digest food properly. Although there is a common treatment called pancreatic enzyme replacement therapy (PERT), it can be difficult for those using feeding tubes. RELiZORB is designed to simplify how these enzymes are delivered, but it has only been tested in patients with a different condition called cystic fibrosis. This study aims to see if RELiZORB is effective for patients with EPI caused by pancreatitis.

To participate in the trial, patients must be hospitalized and diagnosed with moderate or severe EPI, requiring at least half of their nutrition through tube feeds. They should also be able to understand and agree to participate in the study. However, patients with chronic pancreatitis, certain cancers, or those who cannot tolerate tube feeding will not be eligible. Participants in this trial can expect to receive either the RELiZORB product or standard care while helping researchers learn more about managing EPI in tube-fed patients.

Gender

ALL

Eligibility 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