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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01376414
Other study ID # IRB#: 111050
Secondary ID
Status Completed
Phase N/A
First received June 16, 2011
Last updated August 24, 2016
Start date March 2011
Est. completion date March 2015

Study information

Verified date August 2012
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori) colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban academic emergency department (ED) located in Washington, DC.


Description:

The major goal is to study the prevalence of H. pylori using the 13C Urea Breath Test (UBT) in emergency department (ED) patients with non-specific abdominal pain. The investigators plan to enroll 250 patients during the pilot stage of this study. This T2 translational trial aims to apply recommended guidelines for the investigation and management of NSAP and dyspepsia into the practical arena of ED clinical care. The "test-and-treat" approach to symptomatic H. pylori infection has been endorsed by the American Gastroenterological Association (AGA). Patients who test positive for H. pylori by UBT will be treated with clarithromycin-based triple medication therapy as recommended by the American College of Gastroenterology (ACG) at the discretion of the treating physician. The rationale is that successful identification of H. pylori in the ED and initiation of treatment may reduce future risk of gastritis, gastric lymphoma, and gastric cancer, and is cost-effective through reduction of future healthcare costs and symptom severity. Study subjects will be followed for medication compliance, resolution of symptoms, and ability to obtain outpatient follow-up. As part of this study, the investigators will be collecting important information on the ED evaluation of abdominal pain.


Recruitment information / eligibility

Status Completed
Enrollment 212
Est. completion date March 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

For any patient with chief complaint of "ABD", "STOM", "EPIG", "CHEST", "NAUS" "Do you have pain or discomfort or burning in your upper abdomen as the main reason for coming to ER today?"

Exclusion Criteria:

- The patient LESS than 18 years old.

- Patient does NOT speak English NOR has reliable adult translator.

- Patient does NOT have capacity to give consent? (confused/intoxicated/etc.)

- The patient currently is on antibiotics.

- The patient currently is on a PPI. (eg. Prilosec [omeprazole]), protonix [pantoprazole], prevacid [lansoprazole], aciphex [rabeprazole], nexium [esomeprazole]

- The patient has taken bismuth or pepto-bismol today.

- The patient is known to be or suspected to be pregnant.

- The patient UNABLE to walk to H.pylori Breath test.

- The patient had "recent" negative H.pylori test for same symptoms.

- There an "obvious alternative cause" for pain (per attending).

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Urea Breath Test (UBT) for H. pylori infection
13C UBT to detect H. pylori infection. Single bedside test that determines infection in about ten minutes. Test machine is a product of Exalenz bioscience.

Locations

Country Name City State
United States George Washington University Hospital Washington District of Columbia
United States GWU Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain Prevalence of H. pylori infection diagnosed by UBT in patients with symptomatic upper abdominal pain treated in the ED. 6 momths No
Secondary SES measures DoeS SES correlate with HP infection? 6 months No
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