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Recruiting
NCT07418593
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Conditions: Chronic Pancreatitis, Recurrent Acute Pancreatitis, Exocrine Pancreatic Insufficiency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Anna Evans Phillips
Location: Johns Hopkins Medicine Baltimore Maryland
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 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 \ 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
Source: ClinicalTrials.gov (NCT07418593). StuddyBuddy aggregates publicly available trial information.