NCT00584259

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 13, 2010

Status Verified

July 1, 2010

Enrollment Period

3.7 years

First QC Date

December 26, 2007

Last Update Submit

July 12, 2010

Conditions

GERD

Keywords

GERDGastro-Esophageal Disease

Outcome Measures

Primary Outcomes (1)

  • coffee leads to reflux events

    48 hours

Interventions

CoffeeOTHER

3 cups of coffee over a 24 hour period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • those under the age of 18
  • pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Coffee

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Peter Belafsky, MD, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 2, 2008

Study Start

May 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 13, 2010

Record last verified: 2010-07

Locations

US(1)