THE MALABSORPTION BLOOD TEST TRIAL WILL HELP DETERMINE THE BENEFITS OF PANCREATIC ENZYME REPLACEMENT THERAPY IN PATIENTS WITH MILD TO MODERATE EXOCRINE PANCREATIC INSUFFICIENCY.
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Anna Evans Phillips
80 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria3
- ≥ 18 years of age
- RAP (≥ 2 documented lifetime attacks with ≥ 2 of 3 acute pancreatitis criteria) OR Chronic pancreatitis (Cambridge I or II with chronic abdominal pain OR Cambridge III or IV criteria)
- Fecal elastase ≥ 50 within the preceding 12 months
Exclusion Criteria9
- Allergy/Intolerance to PERT/MBT
- Taking medications that alter fat absorption (e.g. orlistat, Ursodeoxycholic acid, etc.)
- Taking GLP-1 Receptor Agonist therapy
- Fecal elastase \<50 within preceding 12 months OR pre-existing diagnosis of severe Exocrine Pancreatic Insufficiency
- Receiving Pancreatic Enzyme Replacement Therapy for \> 5 days within the preceding 90 days
- Acute Pancreatitis attack (documented and meeting at least 2 of 3 criteria) within the preceding 90 days
- History of pancreatic resection or underlying malabsorptive disease
- Pregnant or Breast Feeding
- Other significant medical condition as judged by Principal Investigator
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Interventions
12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
MBT off PERT
MBT on PERT
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07418593