NCT01479231撤回1 期
Predictors of PPI Response in Eosinophilic Esophagitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Prevalence of Gastroesophageal Reflux Disease
研究概览
简要总结
The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.
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
- •18 years of age < 80 years of age
- •14 eosinophils / hpf on biopsies from esophagus
- •Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2"yes", question 4 > "moderate" and question 7 > "once a week")
- •Clinically performed EGD with > 14 eosinophils/hpf completed within last 3 months
排除标准
- •Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
- •Dilatation of esophagus at time of index endoscopy
- •Treatment with topical steroid within 3 months of index endoscopy
- •Treatment with PPI in last 30 days prior to index EGD
- •Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population
研究组 & 干预措施
dexlansoprazole
Experimental
干预措施: dexlansoprazole (Drug)
结局指标
主要结局
Prevalence of Gastroesophageal Reflux Disease
时间窗: 24 hour
Prevalence of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis (EoE) Description: The definition of GERD is acid exposure time of \>4.2% over 24 hour period, as measured by pH monitoring.
次要结局
- Heartburn/regurgitation(30 day)
- Abnormal 24 hour acid exposure(24 hour)
- Ratio of distal/proximal mean esophageal eosinophil number(6 weeks)
- Mean distal eosinophil number(6 weeks)
研究者
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