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临床试验/NCT00883077
NCT00883077Unknown不适用

Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test

Shandong University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

详细描述

Increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. The conventional test methods of permeability is sugar absorption test which is neither reliable and practical. Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. In our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. The fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with history of ulcerative colitis
  • Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation
  • Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
  • Patients complained of hemafecia but colonoscopy revealed only haemorrhoid

排除标准

  • Known cancers or abdominal surgery
  • Scheduled for endoscopic treatment
  • Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
  • Under conditions such as:
  • liver cirrhosis
  • impaired renal function
  • coagulopathy
  • pregnancy
  • breastfeeding
  • Inability to provide informed consent
  • Known allergy to fluorescein sodium

结局指标

主要结局

Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.

时间窗: Within the 30 minutes after injection of fluorescein

次要结局

  • Total sucralose excretion.(Within the 24 hours after drinking of sucralose)

研究者

发起方
Shandong University
申办方类型
Other

研究点 (1)

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