Fat Malabsorption in Chronic Pancreatitis

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: AbbVie; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); NIDDK Sponsored Research Unit at the Phoenix Indian Medical Center; Phoenix Indian Medical Center
• Treatments: Pancreatin; Pancrelipase

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