To assess the 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.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the faecal fat absorption.
Secondary outcome
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
Background summary
Treatment of 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 CP patients, it seems that enzymes are underused and a dietician is
seldom consulted. Half of the patients use <= 6 capsules of 25.000 FIP-E units
of lipase a day and a quarter use <= 3 capsules of 25.000 FIP-E units of lipase
a day. With the median enzyme dose, 69% of patients reported to have
steatorrhoea related complaints and 42% of patients had difficulties
maintaining weight. In order to improve efficacy, physicians should increase
the dosage of pancreatic enzymes. More patients should be referred to a
dietician. However, the quality of dietary advice should be improved by better
training of (specialized) dieticians.
Study objective
To assess the 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.
Study design
This is a prospective, open, comparative study with a linear design with two
sequential phases (observeratory, then patient-monitored).
Intervention
Drawing blood
Feces fat balance
Start treament with pancreatic enzymes together with extensive patient
education
Study burden and risks
Because the maximum amount of 16 capsules of pancreatic enzymes a day according
to the standard guidelines and the Farmacotherapeutisch Kompas will not be
exceeded in this trial, no serious events are foreseen in the medication
prescribed during this trial. The anticipated benefit of the study is that
patients after completion are properly dosed and well treated for their
exocrine insufficiency.
Erasmus Medisch Centrum, 's Gravendijkwal 230
3000 CA Rotterdam
NL
Erasmus Medisch Centrum, 's Gravendijkwal 230
3000 CA Rotterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020303-69-NL |
| CCMO | NL29316.078.10 |