Confocal Endomicroscopy for Non-Erosive Reflux Disease (CE NERD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Response to NERD treatment
研究概览
简要总结
The purpose of this study is to find out if people who have non-erosive reflux disease (NERD) have changes the investigators can see with a microscope (called confocal endomicroscopy) that is used during endoscopy (a camera scope evaluation of the inside of your stomach and swallowing tube). Traditionally the investigators have used trials of acid blocking medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the esophagus) to determine if the investigators think acid is causing troublesome symptoms. The medical community believes that these symptoms are due to increased spaces between the cells that make up the swallowing tube. The investigators can directly see those spaces with a new microscope that the investigators can pass through the camera scope.
Participants will be assigned to take one of two medications omeprazole and sucralfate (both approved medications for stomach symptoms) to treat their symptoms and record how well the treatment works. The investigators then will look to see if the microscope can predict which medication will work best for patients in the future. The investigators also plan to measure the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube and stomach as this is standard for patients with your symptoms. The investigators will compare the results of those studies to the microscope findings.
详细描述
Study entry criteria:
The investigators plan to collaborate with three centers to ensure the data derived from this study is generalizable to academic centers as a whole and also to expedite patient recruitment. The centers that will participate are Virginia Commonwealth University, Ochsner Health System and the Medical University of South Carolina.
Patients over the age of 18 presenting to clinic with symptoms typical for reflux disease will be screened to determine if they wish to participate in the study. The site principal investigator will directly contact potential patients to see if they wish to participate. If they elect to participate they will be provided a copy of the informed consent 24 hours before their first contact with study personnel to allow time to review and determine if the wish to participate. All participants will sign a written informed consent.
Patients who wish to enter into the study and have signed an informed consent will complete a reflux disease questionnaire (RDQ). This questionnaire consists of 12 items assessing various aspects of reflux disease. A score of more than 12 will be required for study entry. Individual with a score less than 12 will not participate further in the study.
Standard of care for patients with gastroesophageal reflux disease (GERD) not responsive to proton pump inhibitors (PPI) is confirmatory testing with esophagogastroduodenoscopy (EGD) to evaluate for erosive esophagitis (EE) and testing for acid exposure to the lower esophagus with pH testing. For the purpose of this study the investigators will perform pH testing off acid suppressing medication. This is a standard test for determining if the patient has acid exposure to the esophagus. Typically patients are placed on twice daily (BID) PPI or sucralfate if testing reveals significant acid exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with reflux disease between the ages of 18 and 79 who have failed a trial of daily PPI.
排除标准
- •Barrett's esophagus
- •Use of high dose proton pump inhibitor within 4 weeks of study entry
- •Esophageal varices
- •Coagulopathy
- •GI 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
Patients will receive proton pump inhibitor therapy with omeprazole twice daily while we observe for improvement in reflux symptoms. We will compare the confocal endomicroscopy images in the responders to non-responders at the end of 8 weeks to determine if confocal endomicroscopy can select patient that would benefit most from proton pump inhibitor therapy.
干预措施: Confocal endomicroscopy (Device)
Proton Pump Inhibitor
Patients will receive proton pump inhibitor therapy with omeprazole twice daily while we observe for improvement in reflux symptoms. We will compare the confocal endomicroscopy images in the responders to non-responders at the end of 8 weeks to determine if confocal endomicroscopy can select patient that would benefit most from proton pump inhibitor therapy.
干预措施: Proton pump inhibitor (Drug)
Sucralfate
Patients will receive sucralfate therapy four times a day while we observe for improvement in reflux symptoms. We will compare the confocal endomicroscopy images in the responders to non-responders at the end of 8 weeks to determine if confocal endomicroscopy can select patient that would benefit most from sucralfate therapy.
干预措施: Confocal endomicroscopy (Device)
Sucralfate
Patients will receive sucralfate therapy four times a day while we observe for improvement in reflux symptoms. We will compare the confocal endomicroscopy images in the responders to non-responders at the end of 8 weeks to determine if confocal endomicroscopy can select patient that would benefit most from sucralfate therapy.
干预措施: Sucralfate (Drug)
结局指标
主要结局
Response to NERD treatment
时间窗: 8 weeks
We will use a validated measure of reflux disease - the reflux disease questionnaire (RDQ). This questionnaire consists of 12 items assessing various aspects of reflux disease. A score of more than 12 will be required for study entry. Response to treatment will be assessed based on reduction in scores on this survey.
次要结局
- Confocal endomicroscopy findings(Immediate)
- Quality of life(8 weeks)