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临床试验/NCT02577640
NCT02577640已完成不适用

Dietary Soy Isoflavones In Chronic Pancreatitis

Ohio State University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Dose Limiting Toxicities

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic pancreatitis by fulfilling one of the following clinical scenarios:
  • Presence of pancreatic calcifications
  • Suggestive for chronic pancreatitis - consistent EUS criteria or at least 3 abnormal side branches on pancreatic duct imaging
  • Indeterminate EUS findings for chronic pancreatitis with evidence of exocrine pancreatic insufficiency (EPI)
  • Age ≥18 years

排除标准

  • 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

结局指标

主要结局

Dose Limiting Toxicities

时间窗: 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.

次要结局

  • Pro-inflammatory Cytokines(1 (dose escalation group) or 4 weeks (maximally tolerated subject))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Hart

Assistant Professor-Clinical

Ohio State University

研究点 (2)

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