Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Anna Evans Phillips
Summary
This project uses the Malabsorption Blood Test (MBT) to identify patients with recurrent acute or chronic pancreatitis who have mild to moderate exocrine pancreatic insufficiency. A subgroup of patients who have response to pancreatic enzyme replacement therapy will enter a randomized, placebo-controlled pilot clinical trial for 8 weeks to identify improvements in quality of life (QOL).
Description
This proposal uses a blood test detection method for EPI specifically designed to detect fat malabsorption in the setting of inadequate release of pancreatic digestive enzymes. The purpose of using it in this study is to identify mild and moderate EPI, for which to date no reliable test exists. The MBT evaluates the absorption of heptadecanoic acid (HA), a fatty acid dependent on lipase to release it from more complex form before it can be absorbed. Steatorrhea (fatty diarrhea) is a symptom present in over half of subjects with severe EPI, but is frequently not present in mild or moderate form…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * ≥ 18 years of age * RAP (≥ 2 documented lifetime attacks with ≥ 2 of 3 acute pancreatitis criteria) OR Chronic pancreatitis (Cambridge I or II with documented history of AP OR Cambridge III or IV criteria) * Fecal elastase ≥ 50 within the preceding 12 months Exclusion Criteria * Allergy/Intolerance to PERT/MBT * Taking medications that alter fat absorption or that supplement the fatty acids being studied (e.g. orlistat, ursodeoxycholic acid, Fatty-15 fatty acid supplement etc.) * Taking GLP-1 Receptor Agonist therapy * Fecal elastase \<50 within preceding 12 months OR p…
Interventions
- DrugPancreatic Enzyme Replacement Therapy
12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)
- DrugPlacebo
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
- Diagnostic TestMBT1
MBT off PERT
- Diagnostic TestMBT 2
MBT on PERT
Locations (2)
- Johns Hopkins MedicineBaltimore, Maryland
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania