New blood test could spot hidden digestive problems in pancreatitis patients
NCT ID NCT07418593
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests a new blood test (Malabsorption Blood Test, or MBT) to find mild-to-moderate pancreatic insufficiency in people with chronic or recurrent acute pancreatitis. A small group of participants who respond to pancreatic enzyme replacement therapy (PERT) will then be randomly assigned to receive either PERT or a placebo for 8 weeks to see if their quality of life improves. The goal is to see if the blood test can guide treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pancreatic Enzyme Replacement Therapy (PERT)
- What this could lead to
- If successful, this blood test could help doctors identify which patients with chronic pancreatitis would benefit from enzyme replacement therapy, potentially improving their quality of life.
- What could go wrong
- This is a small, early-phase pilot study with only 80 participants. The blood test may not accurately identify all patients who need treatment, and the quality-of-life improvements seen may not hold up in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Medicine
NOT_YET_RECRUITINGBaltimore, Maryland, 21287, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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