Enzyme Suppletion in Exocrine Pancreatic Dysfunction (SAPES)

• ClinicalTrials.gov Identifier: NCT01430234
• Recruitment Status: Completed
• First Posted: September 8, 2011
• Last Update Posted: March 11, 2015
• Sponsor: Foundation for Liver Research
• Collaborator: Axcan Pharma
• Information provided by (Responsible Party): Foundation for Liver Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pancreatitis; Exocrine Pancreatic Insufficiency	Drug: Panzytrat 25.000 FIP-E units of Lipase	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen
• Study Start Date: October 2011
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm

Intervention/treatment

Panzytrat fixed dose vs. self-dosing; In Phase I (week 1-4) patients will use the fixed amount of lipase as was prescribed by their treating physician. Phase II (week 5-9) patients will start the self-dosage regimen with pancreatic enzymes (without exceeding the maximum amount of 16 capsules per day). They are properly educated by the researcher and dietician how to adjust the amount of pancreatic enzymes to the fat intake in their diet.

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.; Other Name: Pancreatine of porcine-origin

Outcome Measures

Primary Outcome Measures :

1. Fecal Fat percentage [ Time Frame: week 1, 5 and 9 ]
   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

Secondary Outcome Measures :

1. enzyme dose [ Time Frame: On a weekly base during 9 weeks ]
   Change in enzyme dose
2. Improvement of steatorrhea-related complaints [ Time Frame: On a weekly base during 9 weeks ]
   Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain).
3. Change in dietary habits [ Time Frame: Week 1, 5 and 9 ]
   Change in dietary habits by means of a food diary
4. Patient satisfaction [ Time Frame: Week 4 and 9 ]
   Patient satisfaction by means of a SF36 questionnaire
5. Quality of life [ Time Frame: week 4 and 9 ]
   Quality of life by means of a SF36 questionnaire
6. Evaluation of the nutritional status [ Time Frame: week 5 and 9 ]
   Evaluation of the nutritional status in the blood and calculating the Body Mass Index (BMI)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Netherlands

Erasmus Medical Center

Rotterdam, Zuid-Holland, Netherlands, 3000 WB

Sponsors and Collaborators

Foundation for Liver Research

Axcan Pharma

Investigators

• Principal Investigator: Marco Bruno, MD, PhD; Department of Gastroeneterology and Hepatology, Erasmus University Medical Center

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Foundation for Liver Research
• ClinicalTrials.gov Identifier: NCT01430234
• Other Study ID Numbers: SAPES
• First Posted: September 8, 2011
• Last Update Posted: March 11, 2015
• Last Verified: March 2015

Keywords provided by Foundation for Liver Research:

Chronic pancreatitis; Exocrine insufficiency; Pancreatic enzyme replacement therapy; Self-administration

Additional relevant MeSH terms:

Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases; Pancreatin; Gastrointestinal Agents