Actively Recruiting
Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients
Led by Massachusetts General Hospital · Updated on 2025-04-13
60
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
Alcresta Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with moderate or severe exocrine pancreatic insufficiency (EPI) with a PEI-Q symptom score of 1.4 or greater
- Diagnosed with acute, recurrent acute, or subacute pancreatitis, including infection, pseudocyst, or walled-off pancreatic necrosis
- Currently admitted to the hospital at enrollment
- Requires at least 50% of daily caloric and fluid intake through enteral tube feeds
- Able and willing to provide informed consent
You will not qualify if you...
- Diagnosed with chronic pancreatitis
- Currently intubated and unable to provide consent
- Has active gastrointestinal tract cancer
- Requires less than 50% of nutritional support at enrollment
- Unable to tolerate any form of enteral nutrition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
C
Casey M Luckhurst, MD
CONTACT
Y
Yasmin G Hernandez-Barco, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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