Soy-tomato juice for people with recurrent acute or chronic pancreatitis
Official title: Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
Run by Ohio State University · NCT07447687 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | April 2, 2026 |
| Main results expected | January 14, 2028 |
| Study ends | June 1, 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07447687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.