RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-28
Study Completion:2027-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06691893

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Patient is currently admitted to the hospital at the time of study enrollment.
  4. * Patient requiring at least 50% of daily caloric and fluid intake through enteral tube feeds.
  5. * Patient is able and willing to provide informed consent.
  1. * Patient with chronic pancreatitis
  2. * Patient is currently intubated and unable to provide consent
  3. * Patient with active gastrointestinal tract cancer
  4. * Patient requiring less than 50% of nutritional support at time of enrollment
  5. * Patient is unable to tolerate any form of enteral nutrition

Contacts and Locations

Study Contact

Casey M Luckhurst, MD
CONTACT
617-726-2760
cluckhurst@mgb.org
Yasmin G Hernandez-Barco, MD
CONTACT
yhernandez-barco@mgh.harvard.edu

Principal Investigator

Casey M Luckhurst, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Casey M Luckhurst, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-28
Study Completion Date2027-07-15

Study Record Updates

Study Start Date2025-03-28
Study Completion Date2027-07-15

Terms related to this study

Keywords Provided by Researchers

  • exocrine pancreatic insufficiency
  • pancreatitis
  • RELiZORB
  • lipase
  • enteral nutrition

Additional Relevant MeSH Terms

  • Exocrine Pancreatic Insufficiency (EPI)
  • Pancreatitis