Gastritis, Peptic Ulcer, Peptic Ulcer Perforation, Stomach Ulcer
Conditions
Keywords
dyspepsia, abdominal, pain, helicobacter, pylori, [C06.405.748.398], [C06.405.748.586], [C06.405.748.586.698], [C06.405.748.586.849]
Brief 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.
Detailed 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.
Interventions
OTHERUrea 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.
Sponsors
George Washington University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain | 6 momths | Prevalence of H. pylori infection diagnosed by UBT in patients with symptomatic upper abdominal pain treated in the ED. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SES measures | 6 months | DoeS SES correlate with HP infection? |
Countries
United States
Outcome results
None listed