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临床试验/NCT02154659
NCT02154659已完成不适用

The Difference of Reflux Pattern Between the Patients Who Have Postprandial Reflux Symptoms

Yonsei University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
The difference of reflux pattern at postprandial period between the patients who have postprandial reflux symptoms and the normal people

研究概览

简要总结

Gastroesophageal reflux disease is increasing worldwide. The causes of reflux symptoms are not found exactly. especially, the postprandial reflux symptoms are more common than the all day reflux symptoms. One of the causes of reflux symptoms is the relaxation of the lower sphincter of the esophagus. But, the sphincter relaxation also occur in normal people. But, there is a difference in postprandial reflux pattens between the patients and the normal people. So, in this study, we want to compare the difference of reflux pattern between the patients who have postprandial reflux symptoms and normal people though the 24hr pH monitoring.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 19 years old, male and female
  • normal people (control group, who has no postprandial reflux symptoms
  • patients who have postprandial reflux symptoms (postprandial reflux symptom means that within the last 6 months, postprandial reflux symptoms more than once a week for more than 1 month)

排除标准

  • patients who have nasoesophageal stricture
  • patients who have bleeding tendency
  • patients who have esophageal varix
  • patients who have cardioverter implantation
  • patients who had surgery for esophagus, stomach or duodenum
  • patients who are taking medications, gastrointestinal motility drugs

研究组 & 干预措施

postprandial reflux group

Other

Esophageal pH monitoring is the current gold standard for diagnosis of gastroesophageal reflux disease. It provides direct physiologic measurement of acid in the esophagus and is the most objective method to document reflux disease, assess the severity of the disease and monitor the reflux acidity.

干预措施: 24hr pH monitoring (Device)

normal group

Other

Esophageal pH monitoring is the current gold standard for diagnosis of gastroesophageal reflux disease. It provides direct physiologic measurement of acid in the esophagus and is the most objective method to document reflux disease, assess the severity of the disease and monitor the reflux acidity.

干预措施: 24hr pH monitoring (Device)

结局指标

主要结局

The difference of reflux pattern at postprandial period between the patients who have postprandial reflux symptoms and the normal people

时间窗: Within the 24 hours after the 24hr pH monitoring

Primary Outcome - The difference of reflux pattern at postprandial period between the patients who have postprandial reflux symptoms and the normal people The postprandial reflux symptom means that the symptoms more than once for a week for more than 1 month

次要结局

  • The difference of esophageal reflux pH between the patients who have postprandial reflux symptoms and the normal people(Within the 24 hours after the 24hr pH monitoring)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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