What this study is
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).
What's being tested
- Pancreatic Enzyme Replacement Therapy
Intervention · 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
Intervention · DRUG
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
- MBT1
Intervention · DIAGNOSTIC TEST
MBT off PERT
- MBT 2
Intervention · DIAGNOSTIC TEST
MBT on PERT
Study details
- Sponsor
- Anna Evans Phillips
- Conditions
- Chronic Pancreatitis · Recurrent Acute Pancreatitis · Exocrine Pancreatic Insufficiency
- Enrolling
- 80 people
- Starts
- 2026-04-20
- Est. completion
- 2028-09
- Design
- Triple-blind, randomized, sequential groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openJohns Hopkins Medicine
Baltimore, Maryland, United States
- Yeganeh Pasebani, MD · Contact410-955-5000ypaseba1@jh.edu
- Vikesh K Singh, MD MSc · Principal investigator
Not yet recruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
- Anna E Phillips, MD MS · Contact412-864-7096evansac3@upmc.edu
Recruiting
Study team
Sponsor
Anna Evans Phillips
Study ID STUDY25030126
Principal investigator
Anna E Phillips, MD MS
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.