Recurrent Acute PancreatitisPhase 1/2STOPNCT07447687
Soy Tomato Juice to Improve Outcomes in Pancreatitis
A Phase 1/2 study testing Soy-tomato juice product and Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed in people with Recurrent Acute Pancreatitis and Chronic Pancreatitis, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Acute Pancreatitis, Chronic Pancreatitis
- What is being tested?
- Soy-tomato juice product and Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to 1 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Spencer Harris, 614-293-6255, spencer.harris@osumc.edu
Phil A Hart, MD
About this study
Official title: Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm 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.
Read the detailed description
This is a pilot, single arm, open label clinical trial to assess the tolerability and compliance of a soy-tomato juice dietary intervention in participants with recurrent acute pancreatitis (RAP) / chronic pancreatitis (CP) and evaluate the effects of the diet on inflammation and patient-reported outcomes (PROs). The investigators hypothesize this diet will be well tolerated, reduce measures of systemic inflammation, and potentially improve PROs.
During the trial, participants will complete a 4-week run-in phase where they are asked to consume a modified diet low in soy and lycopene. Then, participants will be provided a soy-tomato juice product to be consumed during the 4-week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed daily.
- Conditions
- Recurrent Acute Pancreatitis, Chronic Pancreatitis
- Being tested
- Soy-tomato juice product, Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed
- Keywords
- Soy, Tomato, Dietary Intervention, abdominal pain, inflammation, lycopene, soy isoflavones, anti-inflammatory diet, medical nutrition, diet, Ohio State University
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic, Abdominal Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy-tomato juice productDietary supplement
A high lycopene tomato (with levels 2-3x higher than typical) will be grown at OSU farms, as we have done previously. Tomatoes will be harvested and transported to OSU's Food Industries Center (Columbus, OH) for processing into juice and canned using commercial methods. A soy isoflavone extract will be acquired from a commercial supplier, tested for isoflavone content, and dosed into the juice before canning. Our juice recipe has been formulated and previously tested to ensure palatability. Proximate analysis (i.e., the information found on a nutrition facts panel) will be collected from our final juice, along with carotenoid and soy isoflavone levels to fully characterize our intervention agent.
Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumedDietary supplement
This is a novel dietary supplement.
| Study group | Role | What they receive |
|---|---|---|
| soy-tomato juice | Experimental | 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. Receives: Dietary Supplement: Soy-tomato juice product; Dietary Supplement: Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Dietary Intervention
Safety will be evaluated by monitoring adverse events throughout the study. Information will be collected through routine study assessments, including participant interactions, diary entries, vital signs, and standard clinical laboratory testing. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). For this study, we define a dose-limiting toxicity (DLT) as the appearance of any adverse event reaching Grade 3-5 toxicity or that otherwise prevents continuation of the intervention.
Adverse events will be graded using established clinical criteria, and the number and severity of events observed during the intervention period will be summarized to determine the rate of dose-limiting toxicities
Measured: From enrollment to the end of treatment at 8 weeks
Assessment of Compliance With the Dietary Intervention (soy)
Participant adherence to the dietary intervention will be monitored using daily self-report diaries, where individuals record how much of the study beverage they consumed each day. These entries will be used to assess overall adherence across the intervention period without disclosing any specific targets or thresholds to participants.
In addition to self-reports, the study will also evaluate biological markers of dietary intake. Levels of compounds derived from the soy components of the beverage (isoflavone metabolites)) will be measured in urine collected before and after the intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Assessment of Compliance With the Dietary Intervention (lycopene)
Description: In addition to self-reports and assessment of soy metabolites, investigators will also evaluate biological markers of dietary intake. Levels of compounds derived from the lycopene components of the beverage will be measured in plasma collected before and after the intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Determine the Change in Inflammatory Marker Levels
Changes in circulating inflammatory markers will be evaluated before and after the dietary intervention. Concentrations (pg/mL) of key markers (Interleukin-5, Interleukin-1beta, Tumor Necrosis Factor-alpha) will be measured using standard laboratory techniques to characterize overall shifts in inflammation-related signaling. The analysis will help determine whether the intervention is associated with measurable changes in the body's inflammatory profile over time.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Apr 2026
- Primary completion14 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Hart, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447687
- Sponsor's protocol ID
- STUDY20252188
- Other IDs
- R01DK138871
- Acronym
- STOP
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
- ClinicalTrials.gov ID
- NCT07447687
- Acronym / sponsor ID
- STOP / STUDY20252188
- Conditions
- Recurrent Acute Pancreatitis, Chronic Pancreatitis
- Keywords
- Soy, Tomato, Dietary Intervention, abdominal pain, inflammation, lycopene, soy isoflavones, anti-inflammatory diet
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 14 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot, single arm, open label clinical trial to assess the tolerability and compliance of a soy-tomato juice dietary intervention in participants with recurrent acute pancreatitis (RAP) / chronic pancreatitis (CP) and evaluate the effects of the diet on inflammation and patient-reported outcomes (PROs). The investigators hypothesize this diet will be well tolerated, reduce measures of systemic inflammation, and potentially improve PROs.
During the trial, participants will complete a 4-week run-in phase where they are asked to consume a modified diet low in soy and lycopene. Then, participants will be provided a soy-tomato juice product to be consumed during the 4-week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label
| Arm | Type | Receives |
|---|---|---|
| soy-tomato juice | Experimental | Dietary Supplement: Soy-tomato juice product, Dietary Supplement: Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed4 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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy-tomato juice productA high lycopene tomato (with levels 2-3x higher than typical) will be grown at OSU farms, as we have done previously. Tomatoes will be harvested and transported to OSU's Food Industries Center (Columbus, OH) for processing into juice and canned using commercial methods. A soy isoflavone extract will be acquired from a commercial supplier, tested for isoflavone content, and dosed into the juice before canning. Our juice recipe has been formulated and previously tested to ensure palatability. Proximate analysis (i.e., the information found on a nutrition facts panel) will be collected from our final juice, along with carotenoid and soy isoflavone levels to fully characterize our intervention agent. | Dietary supplement | soy-tomato juice |
| Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumedThis is a novel dietary supplement. | Dietary supplement | soy-tomato juice |
Primary outcome
Safety of the Dietary Intervention
Time frame: From enrollment to the end of treatment at 8 weeks
Safety will be evaluated by monitoring adverse events throughout the study. Information will be collected through routine study assessments, including participant interactions, diary entries, vital signs, and standard clinical laboratory testing. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). For this study, we define a dose-limiting toxicity (DLT) as the appearance of any adverse event reaching Grade 3-5 toxicity or that otherwise prevents continuation of the intervention. Adverse events will be graded using established clinical criteria, and the number and severity of events observed during the intervention period will be summarized to determine the rate of dose-limiting toxicities
Assessment of Compliance With the Dietary Intervention (soy)
Time frame: From enrollment to the end of treatment at 8 weeks
Participant adherence to the dietary intervention will be monitored using daily self-report diaries, where individuals record how much of the study beverage they consumed each day. These entries will be used to assess overall adherence across the intervention period without disclosing any specific targets or thresholds to participants. In addition to self-reports, the study will also evaluate biological markers of dietary intake. Levels of compounds derived from the soy components of the beverage (isoflavone metabolites)) will be measured in urine collected before and after the intervention.
Assessment of Compliance With the Dietary Intervention (lycopene)
Time frame: From enrollment to the end of treatment at 8 weeks
Description: In addition to self-reports and assessment of soy metabolites, investigators will also evaluate biological markers of dietary intake. Levels of compounds derived from the lycopene components of the beverage will be measured in plasma collected before and after the intervention.
1 secondary outcome
Determine the Change in Inflammatory Marker Levels
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Soy-tomato juice product and Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed in people with Recurrent Acute Pancreatitis and Chronic Pancreatitis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Spencer Harris (614-293-6255, spencer.harris@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Dietary Intervention (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.