Enzyme Suppletion in Exocrine Pancreatic Dysfunction

Chronic Pancreatitis Clinical Trial

— SAPES  

Official title:

Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430234
• Other study ID #: SAPES
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2011
• Last updated: March 10, 2015
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2015
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Exocrine Pancreatic Insufficiency
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Panzytrat 25.000 FIP-E units of Lipase
patients will experiment with Panzytrat (containing 25.000 units of lipase) to a maximum of 16 capsules a day according to general guidelines.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Liver Research	Axcan Pharma

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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

Outcome

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