An observational study in Gastritis, Peptic Ulcer and Peptic Ulcer Perforation, sponsored by George Washington University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-26.
Sponsored by George Washington University · Observational
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.
196 studies on the registry are indexed under Gastritis; 42 are open to participants now.
This study's enrollment of 212 is below the median of 400 across 79 observational studies indexed under Gastritis.
Browse Gastritis studies →George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
Cohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause.
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.
Also known as: 13C, UBT, H. pylori, helicobacter, gastric, ulcers, dyspepsia, emergency, abdominal pain, exalenz
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.
Time frame: 6 momths
SES measures
DoeS SES correlate with HP infection?
Time frame: 6 months
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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George Washington University