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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35552

Enrollment

Registered

2011-09-15

Start date

2011-10-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

enzyme suppletion Exocrine pancreatic insufficiency

Interventions

Drawing blood Feces fat balance Start treament with pancreatic enzymes together with extensive patient education

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients considered for this trial: - are older than 18 years. - suffer from EPI caused by CP. - Fecal Elastase

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the faecal fat absorption.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)