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.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Anna Evans Phillips · Other
Who this trial is looking for
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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).
Trial Locations
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City
State
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Status
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…
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
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