Fat Malabsorption in Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Malabsorption Syndromes
Intervention: Creon36™
Intervention description: 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.
Intervention MeSH terms: Pancrelipase
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic Pancreatitis; Pancreatic Function; Reduced Exocrine Pancreatic Function; Pancreatic Insufficiency

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).
    

Eligibility criteria:

        Inclusion Criteria (CP):

          -  Chronic pancreatitis diagnosis by gastroenterologist. Participants with CP will be
             characterized based on the TIGAR-O (toxic, genetic, autoimmune, recurrent,
             obstructive) etiology system, on pancreatic morphology (Cambridge criteria) when
             available, and on physiological state (exocrine and endocrine function) as recommended
             by the recent American Pancreatic Association Practice Guidelines4.

          -  Age 30-70 years old

          -  Evidence of at-risk for malabsorption including: 1) history of use of and response to
             pancreatic enzyme medication; 2) history of unintentional weight loss; 3) history of
             increased stools per week or fatty stools; and/or 4) other clinical signs or symptoms
             suggestive of fat malabsorption

          -  In usual state of health for past two weeks including no change in medications

          -  Able to consume a moderate fat diet for stool evaluations

          -  Able to participate in the study for about four weeks with two study visits

        Inclusion Criteria (Healthy Volunteers):

          -  Age 30-70 years old

          -  No known chronic disease that would affect dietary intake or fat absorption

          -  In usual state of health for past two weeks, with stable medications, diet and weight

          -  BMI from 18-29

          -  Able to consume a moderate fat diet for stool evaluations

          -  Able to participate in the study for about one week with one study visit

        Exclusion Criteria (CP):

          -  Evidence of normal fat absorption in medical record

          -  Medications that alter fat absorption (i.e. orlistat, other weight loss medications,
             ursodeoxycholic acid)

          -  Allergy to pork products

          -  History of intestinal blockage or fibrosing colonopathy

          -  History of gout, kidney disease, or high blood uric acid (hyperuricemia)

          -  Pregnancy or breast feeding

        Exclusion Criteria (Healthy Volunteers):

          -  Evidence of fat malabsorption

          -  Medications that alter fat absorption (i.e. orlistat, other weight loss medications,
             ursodeoxycholic acid)

          -  Pregnancy or breast feeding