Soy Tomato Juice to Improve Outcomes in Pancreatitis (STOP)

The Ohio State University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic Pancreatitis; Recurrent Acute Pancreatitis

Treatments: 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; Dietary Supplement: Soy-tomato juice product

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07447687

STUDY20252188

R01DK138871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

soy-tomato juice

Experimental group

Description:

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.

Treatment:

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

Dietary Supplement: Soy-tomato juice product