Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
Recruiting
Phase 4
Interventional Study
Exocrine Pancreatic Insufficiency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Ohio State University · Other
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About This Trial
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of \<200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
2. Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 \< 200 µg/g stool obtained within 3 months prior to baseline assessme…
Contacts