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

RecruitingPhase 3

Sponsor: Massachusetts General Hospital

Conditions: Exocrine Pancreatic Insufficiency (EPI), Pancreatitis

Interventions: RELiZORB

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Boston, Massachusetts, United States