Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires
研究概览
简要总结
Do patient's with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids?
详细描述
Eosinophilic esophagitis is an allergy mediated disease in which antigens exposed to the gastrointestinal tract trigger a combined immediate hypersensitivity.
The investigators anticipate that patients with active eosinophilic esophagitis will have increased intestinal permeability on urine collection of sugars. The investigators are not sure whether these findings will be found in patients who have been successfully treated with topical esophageal steroids. Improvement in intestinal permeability would be perceived as indicating that esophageal disease drives the intestinal permeability. Lack of improvement would indicate that eosinophilic esophagitis is a more systemic disease in which increased small bowel permeability is a marker or perhaps important driver of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of 18 and 80 with Eosinophilic Esophagitis diagnosed by compatible symptoms, endoscopic findings, histology and lack of response to proton pump inhibitors or negative pH study.
- •Vulnerable populations, such as those with diminished mental acuity, will be excluded.
- •Patients allergic to Lactulose
- •Women who are pregnant or lactating.
排除标准
- 未提供
结局指标
主要结局
To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires
时间窗: 30 days
heartburn, trouble swallowing
次要结局
- To determine if patients with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids.(2 hours)
研究者
David A. Katzka
Principal Investigator
Mayo Clinic