Soy-Tomato Juice for Pancreatitis

(STOP Trial)

Overseen By Spencer Harris

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ohio State University

Must not be taking: Immunomodulatory medications

Disqualifiers: Recent pancreatitis, Soy allergy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to understand and take part in all parts of the study.

I have been diagnosed with chronic or recurrent acute pancreatitis.

Exclusion Criteria

Previous allergic reaction to soy or tomato products

I have not had pancreatitis, been hospitalized, or had surgery in the past 30 days.

I take immune system-affecting medication every day for a long-term condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants consume a modified diet low in soy and lycopene

4 weeks

1 visit (in-person)

Intervention

Participants consume a soy-tomato juice product daily

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Soy Tomato Juice

How Is the Trial Designed?

Group I: soy-tomato juice Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+