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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154659
• Other study ID #: 4-2013-0680
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 7, 2015

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 7, 2015
• Est. primary completion date: December 7, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• 24hr pH monitoring

Locations

Country	Name	City	State
Korea, Republic of	Yonsei university College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within the 24 hours after the 24hr pH monitoring
Secondary	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