Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 18 years of age
• RAP (≥ 2 documented lifetime attacks with ≥ 2 of 3 acute pancreatitis criteria) OR Chronic pancreatitis (Cambridge I or II with chronic abdominal pain OR Cambridge III or IV criteria)
• Fecal elastase ≥ 50 within the preceding 12 months
Locations
United States
Maryland
Johns Hopkins Medicine
NOT_YET_RECRUITING
Baltimore
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Anna E Phillips, MD MS
Evansac3@upmc.edu
412-864-7096
Backup
Apsara Mishra, BSC
apm179@pitt.edu
412-383-2447
Time Frame
Start Date: 2026-03
Estimated Completion Date: 2028-09
Participants
Target number of participants: 80
Treatments
Active_comparator: MBT1-MBT2
Participants will undergo the MBT off PERT followed by the MBT on PERT. They will not be enrolled in the randomized trial.
Active_comparator: MBT2-MBT1
Participants will undergo MBT on PERT followed by MBT off PERT. Participants will not be enrolled in the randomized clinical trial.
Active_comparator: MBT1-MBT2 Pancreatic Enzyme
Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with PERT.
Active_comparator: MBT1-MBT2 Placebo
Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with placebo.
Active_comparator: MBT2-MBT1 PERT
Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with PERT.
Active_comparator: MBT2-MBT1 Placebo
Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with placebo.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital of Philadelphia, Johns Hopkins University, Digestive Care, Inc.
Leads: Anna Evans Phillips