Blood test to find mild-to-moderate pancreatic enzyme insufficiency and guide enzyme treatment for people with pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses the Malabsorption Blood Test (MBT), which measures absorption of heptadecanoic acid (HA), to detect fat malabsorption due to inadequate pancreatic enzyme release. About 80 adults with recurrent acute pancreatitis or chronic pancreatitis who do not have overt steatorrhea or known severe exocrine pancreatic insufficiency will be enrolled. Participants will undergo MBT before and after five days of pancreatic enzyme replacement therapy (PERT) to identify MBT-responsive cases, and responders will be randomized into an 8-week, placebo-controlled pilot trial of PERT to measure quality-of-life changes. The protocol excludes people on medications that alter fat absorption, those with recent acute attacks, severe EPI, prior pancreatic surgery, pregnancy, or breastfeeding.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting
• Johns Hopkins Medicine
  Baltimore, Maryland, United States Not yet recruiting

Study contacts

• Principal investigator: Anna E Phillips, MD MS — University of Pittsburgh
• Study coordinator: Anna E Phillips, MD MS
• Email: Evansac3@upmc.edu
• Phone: 412-864-7096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.