Soy Tomato Juice to Improve Outcomes in Pancreatitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOhio State University
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Treatments tested in this trial
- 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
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Ohio State University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov