Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry - Effect on Esophageal Motility of Standard Therapy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
研究概览
简要总结
Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution Manometry before and after medical treatment - motility is suspected to change/improve after therapy.
详细描述
After identification of eosinophilic inflammation of the esophagus -> differentiation between GERD and eosinophilic esophagitis (via pH/MII-measurements or PPI-trial) -> High-resolution manometry (HRM) for evaluation of esophageal motility in patients with eosinophilic esophagitis (exclusion of GERD-patients)-> initiation of budesonide-therapy -> after eight weeks of therapy reevaluation of esophageal motility by HRM
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- 否
入选标准
- •patients with eosinophilic inflammation of the esophagus
排除标准
- •refusal to participate in study
- •pregnancy
- •eosinophilic gastroenteritis
- •Achalasia
- •contraindication for gastroscopy / HRM / 24-h-pH/Impedance-monitoring
- •contraindication for therapy with budesonide
- •eosinophilic inflammation due to GERD
结局指标
主要结局
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
时间窗: Two months
Average maximum intra-bolus-pressure (IBP) \[mmHg\] before and after therapy
次要结局
- Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)(Two months)
- Endoscopic evaluation of inflammation before/after therapy(Two months)
- Symptoms before/after therapy(Two months)
研究者
Monther Bajbouj
PD Dr. med.
Technical University of Munich