Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07418593
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 chronic abdominal pain 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 (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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07418593
Study Brief:
Protocol Section:
NCT07418593