Phase 2
N=11
Fat Malabsorption in Chronic Pancreatitis
Chronic Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02849704 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects — 8.3; 17.7 mg*h/dL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Creon36™ (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects |
8.3; 17.7 | <0.001 sig |
| PRIMARY Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects |
90.9; 95.4 | >0.05 |
| PRIMARY Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects |
5728; 5171 | <0.01 sig |
| SECONDARY Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™ |
5702 | >0.05 |
| SECONDARY Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™ |
9.4 | <0.05 sig |
| SECONDARY Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™ |
93 | >0.05 |
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).
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
Data sourced from ClinicalTrials.gov (NCT02849704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.