Chronic Pancreatitis Clinical Trial
— SAPESOfficial title:
Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus Medical Center | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Foundation for Liver Research | Axcan Pharma |
Netherlands,
Bruno MJ, Tytgat GN. [4 patients with painless diarrhea and weight loss]. Ned Tijdschr Geneeskd. 1994 Dec 17;138(51):2529-33. Dutch. — View Citation
Czakó L, Takács T, Lonovics J, Lakner L, Döbrönte Z, Prónai L, Tulassay Z. [Quality of life in the course of enzyme replacement therapy for chronic pancreatitis]. Orv Hetil. 2002 Jun 23;143(25):1521-7. Hungarian. — View Citation
Delhaye M, Meuris S, Gohimont AC, Buedts K, Cremer M. Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis. Eur J Gastroenterol Hepatol. 1996 Jul;8(7):699-703. — View Citation
Rämö OJ, Puolakkainen PA, Seppälä K, Schröder TM. Self-administration of enzyme substitution in the treatment of exocrine pancreatic insufficiency. Scand J Gastroenterol. 1989 Aug;24(6):688-92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fecal Fat percentage | difference in efficacy measured by the fecal fat content during treatment with pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI due to chronic pancreatitis | week 1, 5 and 9 | No |
Secondary | enzyme dose | Change in enzyme dose | On a weekly base during 9 weeks | No |
Secondary | Improvement of steatorrhea-related complaints | Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain). | On a weekly base during 9 weeks | No |
Secondary | Change in dietary habits | Change in dietary habits by means of a food diary | Week 1, 5 and 9 | No |
Secondary | Patient satisfaction | Patient satisfaction by means of a SF36 questionnaire | Week 4 and 9 | No |
Secondary | Quality of life | Quality of life by means of a SF36 questionnaire | week 4 and 9 | No |
Secondary | Evaluation of the nutritional status | Evaluation of the nutritional status in the blood and calculating the Body Mass Index (BMI) | week 5 and 9 | No |
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