Fat Malabsorption in Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Malabsorption Syndromes
Study type: Interventional
Phase: Phase 2

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).
    

Detailed description: 
      Reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI) contributes to poor
      clinical outcome in a number of diseases and conditions. The incidence, mechanism and
      substantial adverse clinical outcomes of pancreatic insufficiency (PI) are well known in
      patients with cystic fibrosis (CF), and the life sustaining role of pancreatic enzyme
      medication in CF care is well established. Much less is known about the incidence and impact
      of RPF/PI in patients with chronic pancreatitis (CP). Reliable non-invasive screening or
      diagnostic tests with acceptable patient burden are not available for RPF/PI.

      This is a cohort study of subjects with CP who will be evaluated before and after pancreatic
      enzyme medication (Creon36™) administration. A cohort of healthy subjects will serve as a
      comparison group and will be evaluated only once.

      Subjects with CP will receive Creon36™, a pancreatic enzyme medication, and fat and energy
      absorption will be evaluated using three methods: MBT, CFA, and BC before and after
      administration of Creon36™. Many patients with CP are at risk for RPF/PI yet they rarely
      undergo diagnostic testing. Pancreatic enzyme medication will likely improve clinical
      outcomes and quality of life in some of those with RPF/PI. A cohort of healthy volunteers
      will be evaluated with the three methods to provide essential comparison data to optimize the
      understanding and interpretation of the findings from the three methods and the RPF/PI cohort
      with CP. There will be no intervention for the healthy cohort.
    

Intervention name(s): Creon36™
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Pancrelipase; CREON
Intervention MeSH terms: Pancrelipase
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chronic Pancreatitis; Pancreatic Function; Reduced Exocrine Pancreatic Function; Pancreatic Insufficiency