Blood test to find mild-to-moderate pancreatic enzyme insufficiency and guide enzyme treatment for people with pancreatitis
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
This project will use the Malabsorption Blood Test to find adults with recurrent acute or chronic pancreatitis who have mild-to-moderate exocrine pancreatic insufficiency and see if pancreatic enzyme replacement for responsive patients improves quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT07418593 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with recurrent acute pancreatitis (≥2 documented attacks) or chronic pancreatitis, without steatorrhea or known severe EPI and with fecal elastase ≥50, who are not taking medications that alter fat absorption, are the intended participants.
Not a fit: Patients with documented severe exocrine pancreatic insufficiency, ongoing steatorrhea, recent PERT use, a recent acute pancreatitis attack, prior pancreatic resection, or other malabsorptive diseases are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could enable earlier detection and treatment of mild-to-moderate pancreatic insufficiency, reducing malnutrition and improving symptoms and quality of life.
How similar studies have performed: The MBT is a relatively novel blood-based method with some preliminary validation for detecting fat malabsorption, but it has limited widespread clinical validation and comparable approaches have not become standard practice.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Medicine — Baltimore, Maryland, United States (Not_yet_recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.