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

NCT02154659 | Completed

• 1 other identifier: 4-2013-0680
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Device: 24hr pH monitoring

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.

Device: 24hr pH monitoring

Interventions

24hr pH monitoring DEVICE

normal group; postprandial reflux group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: June 1, 2014
• Primary Completion: December 7, 2015
• Study Completion: December 7, 2015
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

KR (1)