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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Device: 24hr pH monitoring

• Registration Number: NCT02154659
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-05-30
• Study Start: 2014-06
• Study First Posted: 2014-06-03
• Primary Completion: 2015-12-07
• Study Completion: 2015-12-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. over 19 years old, male and female
2. normal people (control group, who has no postprandial reflux symptoms
3. 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)

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Exclusion Criteria

1. patients who have nasoesophageal stricture
2. patients who have bleeding tendency
3. patients who have esophageal varix
4. patients who have cardioverter implantation
5. patients who had surgery for esophagus, stomach or duodenum
6. patients who are taking medications, gastrointestinal motility drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postprandial reflux group	24hr pH monitoring	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.
normal group	24hr pH monitoring	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei university College of Medicine; 🇰🇷 Seoul, Korea, Republic of