Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Digestive Care, Inc.
• Collaborator: St. Louis University
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic fibrosis

• Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 <75 mcg/g stool at the time of inclusion in the study

• Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes

• > 18 years of age

• Male and female subjects qualify

• Able to swallow capsules

• Clinically stable with no evidence of an acute medical condition

• History of steatorrhea

Exclusion Criteria:

• History of fibrosing colonopathy in CF subjects

• Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months

• Known contraindication, sensitivity or hypersensitivity to porcine pancreatic enzymes

• Active liver disease

• ALT or AST >3 times the upper limit of normal

• Bilirubin >3 times the upper limit of normal

• Acute pancreatitis or acute exacerbation of chronic pancreatitis

• Acute treatment with any systemic (oral or IV) antibiotics two weeks prior to screening

• Subjects on erythromycin unwilling to discontinue the treatment two weeks prior to screening

• Receiving treatment with antacids or H2 receptor blockers or proton pump inhibitors and unable to discontinue these treatments prior to day 1

• Inability to cooperate with or non-compliant with required study procedures

• Pregnant, breast feeding

• Current daily prescribed scheduled use of narcotics (patients requiring PRN use of narcotics are not excluded)

• Poorly controlled diabetes

• A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfering with assessment or enzyme bioavailability

• Stomach pH > 4

• Small bowel disease (i.e. celiac disease)