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

Digestive Care

Status

Terminated

Conditions

Exocrine Pancreatic Insufficiency

Treatments

Drug: placebo

Drug: pancrelipase

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00749099

DCI092206

IRB #14687

Details and patient eligibility

About

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.

Full description

Eligible patients for this placebo-controlled study had confirmed exocrine pancreatic insufficiency with a stool pancreatic elastase of <75 mcg/g. Patients who satisfied all inclusion criteria are prepared for endoscopic placement of three Liguory nasal biliary aspiration catheters: one 8.5 fr. catheter in the distal duodenum for aspiration, one 7.0 fr. catheter in the first portion of the duodenum for infusion of a PEG marker (4 mL/min) and one 7.0 fr. in the stomach for aspiration. Baseline samples are obtained from the gastric and distal duodenal ports and placed on ice. Subjects are then asked to swallow 5 capsules of a placebo (Phase I) or the test drug (PANCRECARB® (pancrelipase) - Phase II) with a standardized Lundh meal. Gastric samples are collected once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). All collected samples were tested for the following parameters to demonstrate bioavailability of enzymes originating from PANCRECARB® (pancrelipase): lipase, amylase and protease activities, pH (bicarbonate), and protein fingerprinting by SDS-PAGE analysis.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)