The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

Healthy Subjects Clinical Trial

Official title:

The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01194544
• Other study ID #: 99033
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2010
• Last updated: March 6, 2011
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
Taiwan	Yung-Fa Chen	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy		1 year	No
Primary	Dietary habit questionnaire		1 year	No