Clinical trial NCT01430234: Enzyme Suppletion in Exocrine Pancreatic Dysfunction
Official title: Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Keywords: Chronic pancreatitis
Exocrine insufficiency
Pancreatic enzyme replacement therapy
Self-administration
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
Collaborators: name: Axcan Pharma
First posted: 2011-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, open, comparative study with a linear design with two sequential phases (observatory, then patient-monitored).

The research population consists of patients who are treated with pancreatic enzymes (\< 6 capsules p/d containing 25,000 units of lipase) for exocrine insufficiency caused by chronic pancreatitis.

After inclusion, patients will discontinue taking pancreatic enzymes during one week (wash-out period). The last four days of this week, a fecal fat balance test will be performed to quantify the fecal fat loss without enzyme correction. If the fecal fat excretion is less than 15%, this is considered normal and therefore the patient will be excluded from the study. Subsequently, the next three weeks of the trial the patient will restart using the same dose of pancreatic enzymes the way it was prescribed before inclusion. The last four days of the fourth week, a fecal fat balance test will be repeated to quantify the fecal fat loss with enzyme correction. After this test the intervention takes place, consisting of a standardised education of the patient by a dietician. In the second phase of four weeks, patients are stimulated to use this information to self-dose the amount of pancreatic enzymes according to the fat content of their diet. In the last week of the study a fecal fat balance test will be repeated.

The primary endpoint is the fecal fat excretion. Secondary endpoints are the change in enzyme dose after intervention, improvement of complaints (e.g. steatorrhoea related complaints, abdominal cramps, abdominal pain), change in dietary habits, patient satisfaction, quality of life, evaluation of the nutritional status, and the occurrence of side effects.

Because the maximum amount of 16 capsules of pancreatic enzymes a day according to the standard guidelines will not be exceeded in this trial, no risks are foreseen. The anticipated benefit of the study is that patients will be treated more effectively for their EPI. The burden of this trial for patients is the repeated fecal fat balance test.

Eligibility 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

Primary outcomes:
measure: Fecal Fat percentage
timeFrame: week 1, 5 and 9
Secondary outcomes:
measure: enzyme dose
timeFrame: On a weekly base during 9 weeks
measure: Improvement of steatorrhea-related complaints
timeFrame: On a weekly base during 9 weeks
measure: Change in dietary habits
timeFrame: Week 1, 5 and 9
measure: Patient satisfaction
timeFrame: Week 4 and 9
measure: Quality of life
timeFrame: week 4 and 9
measure: Evaluation of the nutritional status
timeFrame: week 5 and 9
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Department of Gastroeneterology and Hepatology, Erasmus University Medical Center
name: Marco Bruno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramo OJ, Puolakkainen PA, Seppala K, Schroder TM. Self-administration of enzyme substitution in the treatment of exocrine pancreatic insufficiency. Scand J Gastroenterol. 1989 Aug;24(6):688-92. doi: 10.3109/00365528909093110.
citation: Czako L, Takacs T, Lonovics J, Lakner L, Dobronte Z, Pronai 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.
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.
citation: Bruno MJ, Tytgat GN. [4 patients with painless diarrhea and weight loss]. Ned Tijdschr Geneeskd. 1994 Dec 17;138(51):2529-33. No abstract available. Dutch.