Clinical trial NCT02849704: Fat Malabsorption in Chronic Pancreatitis
Official title: Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pancreatitis
Keywords: Chronic Pancreatitis
Pancreatic Function
Reduced Exocrine Pancreatic Function
Pancreatic Insufficiency
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: AbbVie
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Phoenix Indian Medical Center
First posted: 2016-07-29
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria (CP):

* 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

Inclusion Criteria (Healthy Volunteers):

* 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 (CP):

* 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

Exclusion Criteria (Healthy Volunteers):

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

Primary outcomes:
measure: Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects
timeFrame: 8 hours
measure: Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects
timeFrame: 72 hours
measure: Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects
timeFrame: 72 hours
Secondary outcomes:
measure: Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™
timeFrame: 72 hours
measure: Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™
timeFrame: 8 hours
measure: Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™
timeFrame: 72 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Babette Zemel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Virginia Stallings, MD
role: STUDY_DIRECTOR
References: