Enzyme Suppletion in Exocrine Pancreatic Dysfunction

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the treatment to be effective. In addition, consultation of a specialized dietician is pivotal to educate patients about the proper use of pancreatic enzymes. However, based on a recent prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Liver Research
• Collaborator: Axcan Pharma
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• age ≥ 18 years.

• EPI caused by CP.

• Treated with enzyme therapy (≤ 6 capsules of 25.000 FIP-E units of lipase per day).

• Fecal elastase < 0.200 mg/g

• fecal fat-absorption < 85% without using enzymes.

Exclusion Criteria:

• Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.

• Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat

• Gastroparesis of any aetiology

• Hypersensitivity to pork protein

• Acute pancreatitis

• Limited life-expectancy of ≤ 6 months

• Malignancy of the pancreas

• Pregnancy/lactation