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Malabsorption Blood Test for Pancreatitis

This study is looking at a new blood test called the Malabsorption Blood Test (MBT) to help identify people with chronic pancreatitis or recurrent acute pancreatitis who have mild to moderate exocrine pancreatic insufficiency (EPI). EPI means your pancreas doesn't make enough enzymes to digest food properly. If the MBT shows you respond to Pancreatic Enzyme Replacement Therapy (PERT), you might be randomly assigned to receive either PERT (144,000 lipase units daily) or a placebo (an inactive substance) for 8 weeks. The main goal is to see if PERT improves your quality of life. You can join if you are 18 or older, have a history of pancreatitis, and a fecal elastase level of 50 or higher within the last year. The study's current status is unclear, and it plans to enroll 80 participants.

Study design
This is an interventional study with an unclear status, planning to enroll 80 participants. A subgroup of 12 participants will be randomized to receive either PERT or placebo for 8 weeks.
What's involved
You would undergo the Malabsorption Blood Test (MBT) off PERT and then again on PERT. If you are in the randomized group, you would take either PERT or placebo daily for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured at the start of the randomized controlled trial and again at 8 weeks, when the trial is completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07418593

Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis

Recruiting
PHASE4Ages 18+InterventionalTreatment
Anna Evans Phillips
~80 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Pancreatic Enzyme Replacement TherapyPlaceboMBT1MBT 2

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome (Aim 1)
Measured over 2 weeks
+1 more outcome measured

Conditions

Chronic Pancreatitis
Recurrent Acute Pancreatitis
Exocrine Pancreatic Insufficiency

Explore related trials

Chronic PancreatitisRecurrent Acute Pancreatitis

Where it's being run

2 sites across 2 states
Maryland1
Pennsylvania1

Study leadership

  • Anna E Phillips, MD MS · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Anna E Phillips, MD MS
[email protected]
412-864-7096
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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

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

What this trial measures

  • Primary Outcome (Aim 1)2 weeks

    The primary outcome of the first phase of the study will be the prevalence of responders to PERT by assessing Heptadecanoic Acid absorption following 5-days of PERT therapy compared to baseline (no PERT therapy). This will be measured by a positive area under the curve of the difference between absorption curves for Triheptadecanoic Acid and Pentadecanoic Acid.

  • Primary Outcome (Aim 2)Baseline (at time of entry to RCT) to completion of RCT, 8 weeks

    The primary outcome of the second phase of the study will be change in the Overall Quality of Life Score of the Patient Reported Outcomes Measurement Systems (PROMIS) 29 + 2 questionnaire for subjects receiving PERT compared to placebo.