The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01194544
First received: August 10, 2010
Last updated: March 6, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Dietary habit questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yung-Fa Chen M.D., Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01194544     History of Changes
Other Study ID Numbers: 99033
Study First Received: August 10, 2010
Last Updated: March 6, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Congenital Abnormalities
Food Habits
Habits

ClinicalTrials.gov processed this record on July 29, 2014