NCT07418593 · Anna Evans Phillips
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
(MBT)
What this study is about
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.
View original scientific description
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).
Interventions
DRUG
Pancreatic Enzyme Replacement Therapy
12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)
DRUG
Placebo
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
DIAGNOSTIC_TEST
MBT1
MBT off PERT
DIAGNOSTIC_TEST
MBT 2
MBT on PERT
Primary outcome measures
Primary Outcome (Aim 1)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baltimore, Maryland
- Pittsburgh, Pennsylvania
Collaborators
Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital of Philadelphia, Digestive Care, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations