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CompletedNCT02154659Updated Mar 18, 2019

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

An interventional study of 24hr pH monitoring in Gastroesophageal Reflux Disease, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-18.

Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastroesophageal Reflux Disease
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 81 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Other
    postprandial reflux group

    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

  • Other
    normal group

    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

  • Device24hr pH monitoring
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What researchers measure

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

    Time frame: 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

    Time frame: Within the 24 hours after the 24hr pH monitoring

07

Study locations

1 site
  • Yonsei university College of Medicine
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02154659
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 3, 2014
Start date
Jun 2014
Primary completion
Dec 7, 2015
Completion
Dec 7, 2015
Last update
Mar 18, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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