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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
24hr pH monitoring
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

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

Sites / Locations

  • Yonsei university College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

postprandial reflux group

normal group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

The difference of esophageal reflux pH between the patients who have postprandial reflux symptoms and the normal people

Full Information

First Posted
May 30, 2014
Last Updated
March 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02154659
Brief Title
The Difference of Reflux Pattern Between the Patients Who Have Postprandial Reflux Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 7, 2015 (Actual)
Study Completion Date
December 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
postprandial reflux group
Arm Type
Other
Arm Description
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.
Arm Title
normal group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
24hr pH monitoring
Primary Outcome Measure Information:
Title
The difference of reflux pattern at postprandial period between the patients who have postprandial reflux symptoms and the normal people
Description
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
Time Frame
Within the 24 hours after the 24hr pH monitoring
Secondary Outcome Measure Information:
Title
The difference of esophageal reflux pH between the patients who have postprandial reflux symptoms and the normal people
Time Frame
Within the 24 hours after the 24hr pH monitoring

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Facility Information:
Facility Name
Yonsei university College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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