This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of \<200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.
Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 < 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2).
Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
Ohio State University
Lead sponsor
University of Pittsburgh
Collaborator
University of Illinois at Chicago
Collaborator
University of Southern California
Collaborator
New York University
Collaborator
AbbVie
Collaborator
University of Minnesota
Collaborator