Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen.

Recruiting

• Conditions: enzyme suppletion; 10015674; Exocrine pancreatic insufficiency; 10013317

• Registration Number: NL-OMON35552
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients considered for this trial:
- are older than 18 years.
- suffer from EPI caused by CP.
- Fecal Elastase < 0.200 mg/g
- are using <= 6 capsules of 25.000 FIP-E units of lipase per day.
- fecal fat-absorption < 85% without using enzymes.

Exclusion Criteria

The following are considered as exclusion criteria:
- Subjects who are unwilling or unable to understand and participate in the study and 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the faecal fat absorption. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are:<br /><br>1. Change in enzyme dose after intervention<br /><br>2. Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal<br /><br>pain).<br /><br>5. Change in dietary habits<br /><br>6. Patient satisfaction<br /><br>7. Quality of life<br /><br>3. Evaluation of the nutritional status</p><br>