Clinical Trial: Dietary Soy Isoflavones In Chronic Pancreatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Dietary Soy Isoflavones In Chronic Pancreatitis

Brief Summary: Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease

Detailed Summary: Management of pancreatic disorders imparts a major burden on healthcare costs, estimated at over 3 billion dollars annually. Chronic pancreatitis is characterized by chronic inflammation and progressive scarring, leading to abdominal pain, irreversible damage to the pancreas and the loss of both exocrine and endocrine function. Additionally, chronic pancreatic inflammation is a risk factor for pancreas cancer. There are no current treatments to modify the natural history of this disorder. Thus, identifying novel therapeutic options for this disease represents a high priority, and could fill an unmet medical need to improve quality of life, reduce risk of malignant transformation, and limit exorbitant medical costs associated with patient care. The investigators have assembled a multi-disciplinary research team to pursue an alternative, non-pharmacologic approach to limiting inflammatory cascades in (Chronic Pancreatitis) CP patients. They will assess compliance, toxicity and measure the changes in pro-inflammatory cytokine expression from a soy based dietary bread product using a classic 3+3 dose escalation study design in subjects with chronic pancreatitis.
Sponsor: Ohio State University

Current Primary Outcome: Evaluation of soy bread tolerability [ Time Frame: 1 or 4 weeks ]

Participants will be evaluated for the development of bothersome symptoms and complete dietary evaluations of the soy bread product.


Original Primary Outcome: Evaluation of soy bread [ Time Frame: 1 or 4 weeks ]

Participants will be evaluated for the development of bothersome symptoms and complete dietary evaluations of the soy bread product.


Current Secondary Outcome: Pro-inflammatory cytokines [ Time Frame: 1 or 4 weeks ]

Changes in the serum and urine cytokines will be assessed prior to and following introduction of soy bread.


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: October 7, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: September 29, 2016
Last Verified: September 2016