Dietary Soy Isoflavones In Chronic Pancreatitis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2017 |
| Start Date: | July 2015 |
| End Date: | July 2017 |
Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects
of Food Innovation Science on Gastrointestinal Disease
of Food Innovation Science on Gastrointestinal Disease
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.
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.
Inclusion Criteria:
1. Diagnosis of chronic pancreatitis by fulfilling one of the following clinical
scenarios:
1. Presence of pancreatic calcifications
2. Suggestive for chronic pancreatitis - consistent EUS criteria or at least 3
abnormal side branches on pancreatic duct imaging
3. Indeterminate EUS findings for chronic pancreatitis with evidence of exocrine
pancreatic insufficiency (EPI)
2. Age ≥18 years
Exclusion Criteria:
1. Inability to provide written consent
2. Inability to comply with the study protocol
3. Soy allergy
4. Pancreatic cancer
5. History of prior pancreatic surgery (this does not include endoscopic therapies)
6. Comorbid diseases characterized by a chronic inflammatory state, including, but not
limited to rheumatologic diseases, chronic kidney disease, extra-pancreatic malignancy
7. Pregnancy
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