Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LCMC Health
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evaluate non erosive reflux disease (NERD) Symptoms.
研究概览
简要总结
Primary Objective:
Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings.
Secondary Objectives:
To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Quality of life at study entry and end of study. Compare two medications under study within each group as a subgroup analysis.
详细描述
The purpose of this study is to evaluate response to non-erosive reflux disease (NERD) treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. The researchers will compare two different drug regimens for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In addition, the researchers will be testing the function and effectiveness of the confocal endomicroscopy procedure to be used during the study. Researchers will be continuing to assess the status, symptoms, and any changes associated with the symptoms subjects are experiencing.
The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the esophagus and stomach using a camera in precise detail.
An endoscopy procedure and measurements of acid in the esophagus have been used to determine if the investigators think acid is causing the symptoms. Traditionally, acid blocking medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole, Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the symptoms of NERD.
The medical community believes that these symptoms are due to increased spaces between the cells that make up the esophagus. They can directly see those spaces using the confocal endomicroscopy.
Patients are asked to participate in this study if they are 18 years of age or older and have typical symptoms for patients diagnosed with NERD that have not responded to the first attempted medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals older than 18 years who score a 12 or greater on the Reflux Disease Questionnaire and have failed a four week trial of daily proton pump inhibitor.
- •Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls.
排除标准
- •Barrett's esophagus
- •Use of twice daily proton pump inhibitor within 4 weeks of study entry
- •Esophageal varices
- •Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are not allowed.)
- •Gastrointestinal cancer or mass
- •Previous surgery involving the esophagus, stomach or duodenum
- •Allergy to either sucralfate or proton pump inhibitors
研究组 & 干预措施
Proton Pump Inhibitor (PPI) Therapy
2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks
干预措施: Proton Pump Inhibitor (PPI) Therapy (Drug)
Sucralfate
4x daily Sucralfate slurry, 1g, for 8 weeks
干预措施: Sucralfate (Drug)
结局指标
主要结局
Evaluate non erosive reflux disease (NERD) Symptoms.
时间窗: 20 weeks
Reflux Disease Questionnaire (RDQ)
次要结局
- Compare quality of life in patients with NERD.(20 weeks)
- Compare two medications within each NERD study groups as a subgroup analysis.(20 weeks)
- Evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.(20 weeks)
研究者
Virendra Joshi
Physician, Gastroenterology
LCMC Health