Actively Recruiting
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Led by Anna Evans Phillips · Updated on 2026-04-27
80
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Anna Evans Phillips
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Malabsorption Blood Test (MBT) to identify patients with recurrent acute pancreatitis (RAP) or chronic pancreatitis (CP) who have mild to moderate exocrine pancreatic insufficiency (EPI). The study aims to detect fat malabsorption that current tests cannot reliably identify, especially in patients without obvious symptoms like fatty diarrhea. This is important because undetected EPI can lead to malnutrition, weight loss, muscle loss, bone problems, digestive symptoms, and reduced quality of life (QOL). Participants will undergo the MBT twice: once without pancreatic enzyme replacement therapy (PERT) and once with PERT. About 80 patients will have the MBT to find those who respond to PERT. Among these responders, 24 will enter a randomized, placebo-controlled trial for 8 weeks to receive either PERT (144,000 lipase units daily) or placebo. The study will compare changes in quality of life and gastrointestinal symptoms between these groups. During the study, participants will have the MBT conducted before and after PERT to assess fat absorption. Researchers will measure quality of life using PROMIS questionnaires and examine physical performance and body changes like weight and body mass index. The study includes safety monitoring and will last 8 weeks for the randomized trial portion, with earlier assessments at around 2 weeks for the initial MBT response.
CONDITIONS
Brief Title
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of recurrent acute pancreatitis with at least 2 documented attacks meeting at least 2 of 3 acute pancreatitis criteria, OR chronic pancreatitis defined by Cambridge I or II with history of acute pancreatitis, or Cambridge III or IV criteria
- Fecal elastase level of 50 or higher within the past 12 months
You will not qualify if you...
- Allergy or intolerance to pancreatic enzyme replacement therapy or the Malabsorption Blood Test
- Taking medications that affect fat absorption or supplement the fatty acids studied (e.g., orlistat, ursodeoxycholic acid, Fatty-15 fatty acid supplement)
- Using GLP-1 receptor agonist therapy
- Fecal elastase less than 50 within the past 12 months or diagnosis of severe exocrine pancreatic insufficiency or ongoing steatorrhea
- Use of pancreatic enzyme replacement therapy for more than 5 days within the past 30 days
- Acute pancreatitis attack within the past 90 days
- History of pancreatic surgery or other malabsorptive diseases
- Pregnant or breastfeeding
- Other significant medical conditions as determined by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo the Malabsorption Blood Test (MBT) off and on pancreatic enzyme replacement therapy (PERT) to identify fat malabsorption responsive to treatment.
2 visits (in-person) for MBT testing before and after 5 days of PERT therapy
Duration - 8 weeks
Participants identified as PERT responders are randomized to receive 8 weeks of either PERT supplementation or placebo to assess effects on quality of life and gastrointestinal symptoms.
Weekly visits for assessments during treatment
Duration - Short-term post-treatment period
Participants are monitored to evaluate changes in quality of life, physical performance, and body morphology after treatment completion.
1 to 2 visits depending on assessment schedule
Trial Site Locations
Total: 2 locations
1
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
A
Anna E Phillips, MD MS
A
Apsara Mishra, BSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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