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临床试验/NCT02478944
NCT02478944Unknown不适用

Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

University Hospital Erlangen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings

研究概览

简要总结

Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy

Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.

详细描述

Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up.

No other interventions are administered to participants during this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

  • Inflammatory bowel disease
  • Suspicion of inflammatory bowel disease

排除标准

  • Pregnancy

结局指标

主要结局

Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings

时间窗: 1 year

Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)

时间窗: 1 year

次要结局

  • Manometry findings (peristaltic amplitude values, mmHG) during therapy(1 year)

研究者

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

Francesco Vitali

MD

University Hospital Erlangen

研究点 (2)

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