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Dietary Soy Isoflavones In Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT02577640
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Philip Hart, Ohio State University

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

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Dietary Supplement: Soy bread Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Soy Isoflavones In Chronic Pancreatitis
Study Start Date : July 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Dose Escalation (DE) Phase
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.
Dietary Supplement: Soy bread
Soy breads will be produced using a sponge-dough process. Finished dough will be formed, panned, and proofed in proofing cabinet (~95% RH) at 40ºC for 60 minutes. Proofed loaves will be baked for 50 minutes at 150ºC in a convection oven (jet air oven, model: JA14, Doyon, Liniere, Quebec, Canada). Breads will be considered done at an internal temperature of 95 ± 5ºC.
Other Name: Soy Isoflavones

Experimental: Maximum Tolerated Dose (MTD) Phase
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.
Dietary Supplement: Soy bread
Soy breads will be produced using a sponge-dough process. Finished dough will be formed, panned, and proofed in proofing cabinet (~95% RH) at 40ºC for 60 minutes. Proofed loaves will be baked for 50 minutes at 150ºC in a convection oven (jet air oven, model: JA14, Doyon, Liniere, Quebec, Canada). Breads will be considered done at an internal temperature of 95 ± 5ºC.
Other Name: Soy Isoflavones




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577640


Locations
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United States, Ohio
Philip Hart
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Philip Hart, MD The Ohio State Wexner Medical Center

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Responsible Party: Philip Hart, Assistant Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT02577640     History of Changes
Other Study ID Numbers: 2014H0226
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases