Healthy SubjectsNCT01194544
The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality
An observational study of Healthy Subjects, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: healthy subjects
Who may be able to join
- The healthy subjects undergo EGD in a self-paid health examination in WanFang Hospital.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yung-Fa Chen
Taipei, Taipei, 116
Yung FA Chen, MD, 8862968718572, brother.fa@sn.tpemail.net.tw
About this study
Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an antireflux barrier. Hill et al developed a grading system of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple, reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals provoke considerable postprandial reflux and it results from an increase in the rate of transient lower esophageal sphincter relaxations. One study also revealed that rapid food intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted to evaluate the relationship between dietary habit and GEFV abnormality. The investigators used a questionnaire regarding the dietary habit to the population undergoing EGD in a self-paid health examination.
- Conditions
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| population undergoing EGD in health examination. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy
Measured: 1 year
Dietary habit questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yung-Fa Chen, M.D., Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194544
- Sponsor's protocol ID
- 99033
- Status last verified
- Mar 2011
- First submitted
- 10 Aug 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality
- ClinicalTrials.gov ID
- NCT01194544
- Acronym / sponsor ID
- 99033
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an antireflux barrier. Hill et al developed a grading system of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple, reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals provoke considerable postprandial reflux and it results from an increase in the rate of transient lower esophageal sphincter relaxations. One study also revealed that rapid food intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted to evaluate the relationship between dietary habit and GEFV abnormality. The investigators used a questionnaire regarding the dietary habit to the population undergoing EGD in a self-paid health examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| population undergoing EGD in health examination. | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthy subjects
Key inclusion criteria (1 listed)
- The healthy subjects undergo EGD in a self-paid health examination in WanFang Hospital.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy
Time frame: 1 year
Dietary habit questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yung-Fa Chen, M.D. principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.