Dietary Soy Isoflavones In Chronic Pancreatitis

The Ohio State University

Status: Completed

Conditions: Chronic Pancreatitis

Treatments: Dietary Supplement: Soy bread

Study type: Interventional

Funder types: Other

Identifiers

NCT02577640

2014H0226

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Dose Escalation (DE) Phase

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Soy bread

Maximum Tolerated Dose (MTD) Phase

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Soy bread