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临床试验/NCT02485522
NCT02485522已完成不适用

Diet and Stool Metabolites in Women With Fecal Incontinence

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 28 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
28
试验地点
1
主要终点
Stool butyrate levels

研究概览

简要总结

Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging from 7-15% in community dwelling women. FI has an immense impact on quality of life and is associated with increased care giver burden, increased rates of institutionalization, and significant cost burden in older women. Traditionally believed to be primarily caused by child birth injury, recent studies show that the typical age of onset of FI is age 40 which is remote from child birth. Treatment options for FI are limited because the mechanism underlying FI in older women are poorly understood. The overriding goal of this project is to investigate the relationship between diet, stool metabolites and fecal incontinence.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age greater than 18,
  • parous women with fecal incontinence (defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment),
  • current negative colon cancer screening

排除标准

  • Current bloody diarrhea,
  • current or past diagnosis of colorectal or anal malignancy,
  • diagnosis of inflammatory bowel disease,
  • recent antibiotic treatment,
  • history of immune deficiency diseases,
  • history of recent treatment with immune suppressant medications.

结局指标

主要结局

Stool butyrate levels

时间窗: within 1 week of collection

Pattern of dietary intake by indicator

时间窗: 1 year

次要结局

  • Stool levels of global metabolites(within 1 week of collection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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