Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
RELiZORB
DeviceRELiZORB (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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: No RELiZORBNo intervention 0 interventions
Group B: RELiZORBExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)
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.
Time frame
Measured at 14 days from randomizationSecondary outcomes
1
Time to treatment failure
Treatment failure is defined as no change from baseline or worsening of the PEI-Q symptom score.
Time frame
Measured up to 14 days from randomization2
Biochemical Profile
Change in baseline biochemical profile including Omega 3 Index, Fat-Soluble Vitamins (A, D, E, K), Albumin, Pre-albumin, and C-Reactive Protein.
Time frame
Measured at 30, 60, and 90 days from randomization3
Stool Assessment
Stool consistency and other features indicative of malabsorption (steatorrhea) will be assessed using the Bristol Stool Scale. Patients will also report the presence of steatorrhea (fatty, oily stools) in a stool log. The Bristol Stool Scale is a medical tool used to classify and describe the form of human feces. It consists of seven types of stool, each representing a different consistency or appearance. Types 1 and 2 indicate constipation, while types 6 and 7 indicate diarrhea. Types 3 and 4 are considered normal and ideal for digestive health.
Time frame
Measured at 30, 60, and 90 days from randomization4
Time to oral nutrition
This is defined as the cessation of tube feeding and it serves as an important metric in evaluating patients with EPI, as it may act as a surrogate measure for the restoration of adequate digestive function.
Time frame
Measured up to 90 days from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Alcresta Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov