H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastritis Peptic Ulcer Peptic Ulcer Perforation Stomach Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non specific upper abdominal pain

Cohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause.

Urea Breath Test (UBT) for H. pylori infection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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13C UBT H. pylori helicobacter gastric ulcers dyspepsia emergency abdominal pain exalenz

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No