Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This goal of this clinical trial is to see if people with recurrent acute pancreatitis or chronic pancreatitis can tolerate and regularly drink a tomato juice beverage. Researchers will also measure inflammation and ask participants to report how they feel. Everyone in the study will receive the tomato juice drink, and both participants and researchers will know what is being taken. The investigators expect the drink will be well tolerated, may lower inflammation, and may improve participant-reported symptoms and quality of life.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosis of definite chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP)
• Patients should be able to fully understand and participate in all aspects of the study
Locations
United States
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Contact Information
Primary
Spencer Harris
spencer.harris@osumc.edu
614-293-6255
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2028-06
Participants
Target number of participants: 35
Treatments
Experimental: soy-tomato juice
4 week run-in phase where they are asked to consume a diet low in soy and lycopene, then they will receive the intervention for 4 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Ohio State University