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NCT00584259 Clinical Trial

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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584259
Other study ID # 200614348-2
Secondary ID
Status Completed
Phase N/A
First received December 26, 2007
Last updated July 12, 2010
Start date May 2006
Est. completion date January 2010

Study information
Verified date July 2010
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Coffee
3 cups of coffee over a 24 hour period

Locations
Country Name City State
United States University of California Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary coffee leads to reflux events 48 hours No
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