Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Brief Esophageal Dysphagia Questionnaire
研究概览
简要总结
A prospective longitudinal, observational study of adolescent and adults that will identify novel metabolites associated with dysphagia in Eosinophilic Esophagitis (EoE).
详细描述
In this study, the investigators seek to understand whether a metabolomic profile obtained from esophageal samples correlate with the symptom of dysphagia in adolescent and adults. The investigators hypothesize that intraluminal secreted metabolite(s) will change during episodes of dysphagia. The aim of the study will be to use a novel method of producing esophageal luminal samples, the esophageal string test, to capture esophageal metabolites when a patient is and is not experiencing dysphagia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with Eosinophilic Esophagitis (EoE) and seen either at Children's Hospital Colorado or University of Colorado Hospital for scheduled outpatient clinical assessment or upper GI endoscopy
排除标准
- •Acute food impaction at time of study
- •Recent (within 2 months) use of systemic steroids
- •Other known esophageal disease or esophageal injury (e.g. tracheoesophageal fistula, congenital stricture, caustic injury)
- •known other inflammatory bowel disease
- •inability to swallow the EST
研究组 & 干预措施
EST
All subjects enrolled into the study will:
- Complete a clinical history
- Have vitals obtained
- Complete Patient-reported outcomes
- Have Esophageal mucosal biopsies collected as part of standard of care at the time of the most recent endoscopy to report the peak eosinophilia per hpf.
- Complete the Esophageal String test
干预措施: Esophageal String Test (Procedure)
结局指标
主要结局
Brief Esophageal Dysphagia Questionnaire
时间窗: Time of Endoscopic Procedure
Positive Dysphagia symptoms Measured by Brief Esophageal Dysphagia Questionnaire. The questionnaire asks questions about dysphagia symptoms and the scale is from 0 (rarely/never) to 5 (several times per day).
次要结局
未报告次要终点