Dietary Soy Isoflavones In Chronic Pancreatitis

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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)
Age ≥18 years

Exclusion Criteria

Inability to provide written consent
Inability to comply with the study protocol
Soy allergy
Pancreatic cancer
History of prior pancreatic surgery (this does not include endoscopic therapies)
Comorbid diseases characterized by a chronic inflammatory state, including, but not limited to rheumatologic diseases, chronic kidney disease, extra-pancreatic malignancy
Pregnancy

Arm && Interventions

Group	Intervention	Description
Dose Escalation (DE) Phase	Soy bread	Here a traditional 3+3 design will be used to determine the compliance, tolerability and dose limiting toxicities in this unique patient population. Dose escalation with soy bread will be continued until dose-limiting toxicities are observed in \>33% of the participants or the daily target dose of 4 slices of bread \[132 mg soy isoflavone\] is reached.
Maximum Tolerated Dose (MTD) Phase	Soy bread	After the Phase I study has been completed, an additional 10 chronic pancreatitis patients will be treated at the best tolerated dose of soy bread for 4 weeks to further verify safety and toxicity.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities	1 (dose escalation groups) or 4 (maximally tolerated dose) weeks	Participants were evaluated for the development of bothersome symptoms that prevented them from being able to complete the recommended intervention course. Counts represent number of subjects who developed a symptom that prevented the ability to complete the dose/study period.

Secondary Outcome Measures

Name	Time	Method
Pro-inflammatory Cytokines	1 (dose escalation group) or 4 weeks (maximally tolerated subject)	Changes in the serum were assessed for TNF-alpha prior to and following introduction of soy bread