Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02849704
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT02849704
Study Brief:
Protocol Section:
NCT02849704