Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Esophageal Mucosal Impedance (MI)
研究概览
简要总结
Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?
And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Adults ages 18-90 undergoing clinically indicated upper endoscopy
- •Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
- •Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or Gastroesophageal reflux disease (GERD) with normal appearing esophageal mucosa.
排除标准
- •Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
- •Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- •Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
研究组 & 干预措施
Active Eosinophilic Esophagitis
Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
干预措施: Mucosal Impedance (Device)
Active Eosinophilic Esophagitis
Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
干预措施: Upper Endoscopy (Procedure)
Inactive Eosinophilic Esophagitis
Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
干预措施: Mucosal Impedance (Device)
Inactive Eosinophilic Esophagitis
Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
干预措施: Upper Endoscopy (Procedure)
Control group
Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy
干预措施: Upper Endoscopy (Procedure)
结局指标
主要结局
Esophageal Mucosal Impedance (MI)
时间窗: baseline to one year
An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.
次要结局
未报告次要终点
研究者
David A. Katzka
Principal Investigator
Mayo Clinic