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Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584259
First received: December 26, 2007
Last updated: July 12, 2010
Last verified: July 2010
History of Changes
  Purpose

Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.


Condition Intervention
GERD
 Other: Coffee

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • coffee leads to reflux events [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Coffee
    3 cups of coffee over a 24 hour period
Detailed Description:

Many patients with gastro-esophageal reflux disease (GERD) report that drinking coffee causes heartburn. The purpose of this study is to investigate the effects of coffee on gastro-esophageal acid reflux, and its relation to esophageal motility parameters in patients who are already scheduled to undergo 48 hour wireless pH testing as a result of having symptoms suggestive of GERD. The specific aims are to evaluate the effects of coffee on GERD during daily life and to elucidate the underlying pathogenic mechanism by which coffee induces reflux.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • persons undergoing wireless pH testing for diagnosis and treatment of GERD

Exclusion Criteria:

  • those under the age of 18
  • pregnant and lactating women
  • those who do not meet the inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584259

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Peter Belafsky, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Peter Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00584259     History of Changes
Other Study ID Numbers: 200614348-2
Study First Received: December 26, 2007
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
GERD
Gastro-Esophageal Disease

Additional relevant MeSH terms:
Esophageal Diseases
Gastroesophageal Reflux
Gastrointestinal Diseases
 Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on May 23, 2013