NCT01194544

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

11 months

First QC Date

August 10, 2010

Last Update Submit

March 6, 2011

Conditions

Outcome Measures

Primary Outcomes (2)

  • Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy

    1 year

  • Dietary habit questionnaire

    1 year

Study Arms (1)

population undergoing EGD in health examination.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy subjects

You may qualify if:

  • The healthy subjects undergo EGD in a self-paid health examination in WanFang Hospital.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yung-Fa Chen

Taipei, Taipei, 116, Taiwan

RECRUITING

Study Officials

  • Yung-Fa Chen, M.D.

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2010

First Posted

September 3, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations