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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non specific upper abdominal pain | Cohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urea Breath Test (UBT) for H. pylori infection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SES measures | DoeS SES correlate with HP infection? | 6 months |
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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:
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All adult patients (>18 years) presenting to the ED with symptoms of abdominal pain will be screened for eligibility. The ED is a single site urban academic level one trauma center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States | ||
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| D010437 | Peptic Ulcer |
| D010439 | Peptic Ulcer Perforation |
| D013276 | Stomach Ulcer |
| D004415 | Dyspepsia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D004636 | Emergency Service, Hospital |
| ID | Term |
|---|---|
| D006748 | Hospital Departments |
| D006739 | Hospital Administration |
| D058016 | Health Facility Administration |
| D006268 | Health Facilities |
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|
| GWU Hospital |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| D004378 |
| Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D005159 | Health Care Facilities Workforce and Services |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |