Clinical Trial: Fat Malabsorption in Chronic Pancreatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis

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 Summary:

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.


Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Difference in mean malabsorption blood test (MBT) between groups [ Time Frame: Up to 72 hours ]

The fat and energy absorption pattern in CP subjects after treatment with Creon36™ will be compared with healthy controls. Mean MBT will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat and energy absorption pattern between the two groups.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: July 27, 2016
Date Started: July 2016
Date Completion: March 2018
Last Updated: April 19, 2017
Last Verified: April 2017