Actively Recruiting
Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
Led by Ohio State University · Updated on 2026-03-03
35
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether people with recurrent acute pancreatitis or chronic pancreatitis can tolerate and regularly drink a soy-tomato juice beverage. This pilot, single arm, open label clinical trial aims to assess the effects of this dietary intervention on inflammation and patient-reported symptoms and quality of life. The study is led by Ohio State University and is designed to explore safety, compliance, and potential improvements in these conditions. Participants will first complete a 4-week run-in phase where they follow a diet low in soy and lycopene. After this, they will consume about 12 ounces of a soy-tomato juice product daily during a 4-week intervention phase. The juice is made from high lycopene tomatoes combined with soy isoflavones, prepared and canned using commercial methods. Both participants and researchers will know that the juice is being consumed. Throughout the 8-week study period, researchers will monitor safety and track how well participants follow the dietary intervention by measuring soy and lycopene levels. They will also measure changes in inflammatory markers and collect patient-reported outcomes on symptoms and quality of life. This helps evaluate the tolerability and potential benefits of the soy-tomato juice in people with pancreatitis.
CONDITIONS
Brief Title
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of definite chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP)
- Ability to fully understand and participate in all aspects of the study
- Age between 18 and 80 years
You will not qualify if you...
- Episode of acute pancreatitis, hospitalization, or endoscopic/surgical intervention within 30 days of enrollment
- Chronic, daily use of systemic immunomodulatory medication for any indication
- Previous allergic reaction to soy or tomato products
- Known pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants follow a modified diet low in soy and lycopene to prepare for the intervention.
Duration - 4 weeks
Participants consume about 12 ounces (two small cans) of soy-tomato juice daily as the dietary intervention.
Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
S
Spencer Harris
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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