RECRUITING Phase 4 ClinicalTrials.gov

Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis

Sponsor: Anna Evans Phillips • ClinicalTrials.gov ID: NCT07418593

Registry updated: 2026-09-11

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Description

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).

Interventions

Pancreatic Enzyme Replacement Therapy (Drug)
12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)
Placebo (Drug)
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
MBT1 (Diagnostic test)
MBT off PERT
MBT 2 (Diagnostic test)
MBT on PERT

Eligibility criteria

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 pre-existing diagnosis of severe Exocrine Pancreatic Insufficiency, or ongoing steatorrhea * Receiving Pancreatic Enzyme Replacement Therapy for \> 5 days within the preceding 30 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

Conditions

Chronic Pancreatitis Recurrent Acute Pancreatitis Exocrine Pancreatic Insufficiency

Locations

Johns Hopkins Medicine — Baltimore, Maryland, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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