Back to resultsEffect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
Primary Purpose
GERD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coffee
Sponsored by
About this trial
This is an interventional supportive care trial for GERD focused on measuring GERD, Gastro-Esophageal Disease
Eligibility 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
Sites / Locations
- University of California Davis Medical Center
Outcomes
Primary Outcome Measures
coffee leads to reflux events
Secondary Outcome Measures
Full Information
NCT ID
NCT00584259
First Posted
December 26, 2007
Last Updated
July 12, 2010
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT00584259
Brief Title
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
Official Title
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
GERD, Gastro-Esophageal Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Coffee
Intervention Description
3 cups of coffee over a 24 hour period
Primary Outcome Measure Information:
Title
coffee leads to reflux events
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Belafsky, MD, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
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