Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnna Evans Phillips
About this trial
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).
Eligibility criteria
Qualifiers
≥ 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pancreatic Enzyme Replacement Therapy
- Placebo
- MBT1
- MBT 2
Treatment groups
80 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Anna Evans Phillips
Lead sponsor
University of Pittsburgh
Sponsor institution
Johns Hopkins University
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Children's Hospital of Philadelphia
Collaborator
Digestive Care, Inc.
Collaborator
Source ClinicalTrials.gov