Fat Malabsorption in Chronic Pancreatitis

NCT ID: NCT02849704

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-13
• Study Completion Date: 2017-11-01

Brief Summary

The objective of this study is to evaluate the malabsorption blood test (MBT), stool coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI). A further objective is to determine the test responses before and after pancreatic enzyme medication administration (Creon36™) in the patients with chronic pancreatitis (CP).

Detailed Description

Reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI) contributes to poor clinical outcome in a number of diseases and conditions. The incidence, mechanism and substantial adverse clinical outcomes of pancreatic insufficiency (PI) are well known in patients with cystic fibrosis (CF), and the life sustaining role of pancreatic enzyme medication in CF care is well established. Much less is known about the incidence and impact of RPF/PI in patients with chronic pancreatitis (CP). Reliable non-invasive screening or diagnostic tests with acceptable patient burden are not available for RPF/PI.

This is a cohort study of subjects with CP who will be evaluated before and after pancreatic enzyme medication (Creon36™) administration. A cohort of healthy subjects will serve as a comparison group and will be evaluated only once.

Subjects with CP will receive Creon36™, a pancreatic enzyme medication, and fat and energy absorption will be evaluated using three methods: MBT, CFA, and BC before and after administration of Creon36™. Many patients with CP are at risk for RPF/PI yet they rarely undergo diagnostic testing. Pancreatic enzyme medication will likely improve clinical outcomes and quality of life in some of those with RPF/PI. A cohort of healthy volunteers will be evaluated with the three methods to provide essential comparison data to optimize the understanding and interpretation of the findings from the three methods and the RPF/PI cohort with CP. There will be no intervention for the healthy cohort.

Conditions

Chronic Pancreatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Chronic Pancreatitis (CP) Subjects

CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary.

Subjects will take Creon36™ for 9 days.

Subjects will have two study visits, one before and one after treatment initiation with Creon36™. Both visits will be identical with the exception of completion of questionnaires and fecal elastase assessment (only Visit 1).

Group Type: EXPERIMENTAL

Creon36™

Intervention Type: DRUG

Creon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.

Healthy Controls

Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Creon36™

Creon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.

Intervention Type: DRUG

Other Intervention Names

Pancrelipase; CREON

Eligibility Criteria

Inclusion Criteria

• Chronic pancreatitis diagnosis by gastroenterologist. Participants with CP will be characterized based on the TIGAR-O (toxic, genetic, autoimmune, recurrent, obstructive) etiology system, on pancreatic morphology (Cambridge criteria) when available, and on physiological state (exocrine and endocrine function) as recommended by the recent American Pancreatic Association Practice Guidelines4.
• Age 30-70 years old
• Evidence of at-risk for malabsorption including: 1) history of use of and response to pancreatic enzyme medication; 2) history of unintentional weight loss; 3) history of increased stools per week or fatty stools; and/or 4) other clinical signs or symptoms suggestive of fat malabsorption
• In usual state of health for past two weeks including no change in medications
• Able to consume a moderate fat diet for stool evaluations
• Able to participate in the study for about four weeks with two study visits

• Age 30-70 years old
• No known chronic disease that would affect dietary intake or fat absorption
• In usual state of health for past two weeks, with stable medications, diet and weight
• BMI from 18-29
• Able to consume a moderate fat diet for stool evaluations
• Able to participate in the study for about one week with one study visit

Exclusion Criteria

• Evidence of normal fat absorption in medical record
• Medications that alter fat absorption (i.e. orlistat, other weight loss medications, ursodeoxycholic acid)
• Allergy to pork products
• History of intestinal blockage or fibrosing colonopathy
• History of gout, kidney disease, or high blood uric acid (hyperuricemia)
• Pregnancy or breast feeding

• Evidence of fat malabsorption
• Medications that alter fat absorption (i.e. orlistat, other weight loss medications, ursodeoxycholic acid)
• Pregnancy or breast feeding

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Phoenix Indian Medical Center

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Babette Zemel, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Virginia Stallings, MD

Role: STUDY_DIRECTOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-013001

Identifier Type: -

Identifier Source: org_study_id