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The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194544
First Posted: September 3, 2010
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  Purpose
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.

Condition
Healthy Subjects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy [ Time Frame: 1 year ]
  • Dietary habit questionnaire [ Time Frame: 1 year ]

Estimated Enrollment: 600
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
population undergoing EGD in health examination.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy subjects
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194544


Locations
Taiwan
Yung-Fa Chen Recruiting
Taipei, Taiwan, 116
Contact: Yung FA Chen, MD    8862968718572    brother.fa@sn.tpemail.net.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Yung-Fa Chen, M.D. Taipei Medical University WanFang Hospital
  More Information

Responsible Party: Yung-Fa Chen M.D., Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01194544     History of Changes
Other Study ID Numbers: 99033
First Submitted: August 10, 2010
First Posted: September 3, 2010
Last Update Posted: March 8, 2011
Last Verified: March 2011