Intestinal Barrier Permeability Defects, Recovery, and Risk of Bacterial Translocation Induced After Deep Intestinal Manipulation by Balloon-assisted Enteroscopy: From Basic to Clinical Research
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- molecular bacteremia
研究概览
简要总结
- Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
- Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
- However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
- We will also examine relevant patient factors.
详细描述
The newly developed balloon-assisted enteroscopy systems allow insertion of the enteroscopy deeply into the small intestines by fixation of the soft, redundant small intestines with an inflatable balloon over the tip of the overtube. However, the inflation of balloon might stimulate the intestinal mucosa, and the deep manipulation of intestinal segments might also compromise the intestinal barrier function. According to our preliminary experience of balloon-assisted enteroscopy (which is among the first groups in Taiwan), we experienced a significant case of suspected post-procedural bactermia patient. Besides, there is also a published case report from the UK reporting Streptococcus milleri bacteremia which is suspected as bacterial translocation after balloon-assisted enteroscopy. However, currently there is no original study focusing on the intestinal barrier / permeability defects or bacterial translocation. This is a timely and novel research topic in the current developing era of balloon-assisted enteroscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations
- •signed written informed consents
排除标准
- •Patients with active infection or receiving systemic (oral or intravenous) antibiotics within recent 3 months (this may decrease effect of bacterial translocation) or taking drugs that may affect renal function within 3 months
- •Unstable health condition for balloon-assisted enteroscopy (unstable hemodynamics, severe cardiopulmonary compromise)
- •Pregnancy
- •known allergy to lactulose, mannitol
- •Refuse to sign written informed consent of this study.
- •patients would be advised to hold prokinetic agents
结局指标
主要结局
molecular bacteremia
时间窗: 7d
次要结局
未报告次要终点
