At a glance
ClinicalIndex Comparison Record- ✓Confirmed chronic pancreatitis diagnosis by gastroenterologist
- ✓Age 30-70 years old
- ✓Evidence of malabsorption risk: prior pancreatic enzyme use/response, unintentional weight loss, increased stools or fatty stools, or other clinical signs of fat malabsorption
- ✓Stable health for past two weeks with no medication changes
- ✕Evidence of normal fat absorption
- ✕Medications that alter fat absorption (orlistat, weight loss drugs, ursodeoxycholic acid)
- ✕Allergy to pork products
- ✕History of intestinal blockage or fibrosing colonopathy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis
In Brief
A Phase 2 clinical trial evaluating Creon36™ for Chronic Pancreatitis. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the malabsorption blood test (MBT), stool coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI). A further objective is to determine the test responses before and after pancreatic enzyme medication administration (Creon36™) in the patients with chronic pancreatitis (CP).
Study Details
Timeline
Interventions
Creon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.