Soy-tomato juice for people with recurrent acute or chronic pancreatitis
Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
This will try giving daily soy-tomato juice to people with recurrent acute or chronic pancreatitis to see if they can tolerate it and whether it reduces inflammation and symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07447687 on ClinicalTrials.gov |
What this trial studies
This pilot, single-arm, open-label study asks adults with recurrent acute or chronic pancreatitis to complete a 4-week run-in low-soy/low-lycopene diet and then drink about 12 ounces of a soy-tomato juice product daily for 4 weeks. All participants receive the juice and both participants and researchers know what is being taken. Investigators will monitor tolerability and compliance, measure blood markers of systemic inflammation, and collect patient-reported outcomes including abdominal pain and quality of life. The main goal is to determine acceptability and look for signals of reduced inflammation or symptom improvement to justify larger controlled trials.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of chronic pancreatitis or recurrent acute pancreatitis who can understand the protocol and attend visits at the study site are the intended participants.
Not a fit: People with an acute pancreatitis episode, hospitalization, or endoscopic/surgical intervention within 30 days, those on chronic systemic immunomodulatory drugs, anyone with soy or tomato allergies, or pregnant individuals would not be expected to benefit or be eligible.
Why it matters
Potential benefit: If successful, this simple, low-risk beverage could help lower inflammation and improve symptoms or quality of life for people with pancreatitis.
How similar studies have performed: The specific soy-tomato beverage approach is largely novel in pancreatitis, although related dietary anti-inflammatory interventions have shown modest benefits in other inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Spencer Harris
- Email: spencer.harris@osumc.edu
- Phone: 614-293-6255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.