35 Participants NeededMy employer runs this trial

Soy-Tomato Juice for Pancreatitis

(STOP Trial)

SH
Overseen BySpencer Harris
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a soy-tomato juice is tolerable and beneficial for individuals with recurrent acute pancreatitis or chronic pancreatitis. Researchers aim to determine if regular consumption of this juice can reduce inflammation and improve symptoms. Participants will drink the soy-tomato juice for a set period, with both participants and researchers aware of the consumption. Individuals with a confirmed diagnosis of chronic or recurrent acute pancreatitis who can fully participate in the study might be a good fit. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking insights.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using systemic immunomodulatory medication daily, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that drinking soy-tomato juice might help reduce inflammation in people with pancreatitis. In previous studies, participants who included soy-tomato juice in their diet experienced a noticeable drop in substances like IL-5 and TNF-alpha, which are linked to inflammation and pain.

These studies also suggest that the juice is generally well-tolerated, with no major side effects reported. Participants did not experience serious problems. The main goal was to determine if people could drink the juice without issues and if it could alleviate symptoms like pain.

Overall, the findings suggest that soy-tomato juice is safe for short-term consumption and might help reduce inflammation, potentially improving well-being.12345

Why do researchers think this study treatment might be promising for pancreatitis?

Soy-tomato juice is unique because it combines soy and tomatoes to leverage their natural anti-inflammatory properties, which could be beneficial for treating pancreatitis. Unlike traditional treatments that often involve medications like enzyme supplements and pain management, this approach uses a dietary intervention with soy and lycopene (from tomatoes) as active ingredients. Researchers are excited about this treatment because it offers a non-pharmaceutical option that may reduce inflammation naturally, potentially leading to fewer side effects and a more holistic approach to managing pancreatitis. This innovative method could complement existing treatments, providing a novel way to alleviate symptoms.

What evidence suggests that soy-tomato juice might be an effective treatment for pancreatitis?

Research shows that a diet rich in soy and tomatoes might help reduce inflammation and pain for people with chronic pancreatitis. Earlier studies in mice found that this diet improved health compared to a regular diet. In human studies, drinking tomato-soy juice for four weeks significantly lowered certain proteins linked to inflammation, including IL-5, IL-12p70, and GM-CSF. The juice also increased levels of lycopene, a beneficial compound in tomatoes. This trial will evaluate the effects of soy-tomato juice on inflammation in pancreatitis, building on these promising findings.12345

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with chronic pancreatitis or recurring acute pancreatitis who can understand and participate in the study. People cannot join if they are allergic to soy or tomato, recently had a severe pancreatitis episode, use certain immune medications daily, or are pregnant.

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.
See 1 more

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

Trial Overview

The study tests whether people with pancreatitis can tolerate drinking about 12 ounces of a soy-tomato juice each day for 4 weeks. All participants receive the juice, and both researchers and participants know what is being taken.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: soy-tomato juiceExperimental Treatment2 Interventions

Find a Clinic Near You

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+

Citations

Soy Tomato Juice to Improve Outcomes in Pancreatitis

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 ...

Soy-tomato enriched diet reduces inflammation and disease ...

Mice with CP on a soy-tomato diet showed improvements in every activity measure tested compared to control diet-fed CP mice, similar to the ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33311549/

Soy-tomato enriched diet reduces inflammation and disease ...

These pre-clinical results indicate that a soy-tomato enriched diet may be a novel treatment approach to reduce inflammation and pain in patients with CP.

(PDF) Soy-tomato enriched diet reduces inflammation and ...

Consistent with this study, work from our groups have shown in a mouse model of chronic pancreatitis that tomato-soy intake significantly reduces systemic IL-5 ...

Soy-Tomato Juice for Pancreatitis (STOP 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 ...