Clinical trial NCT01376414: H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department
Official title: Pilot Study to Estimate the Prevalence of Helicobacter Pylori (H. Pylori) Infection in Patients Presenting With Non-specific Upper Abdominal Pain to the Emergency Department (ED.)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastritis
Peptic Ulcer
Peptic Ulcer Perforation
Stomach Ulcer
Keywords: dyspepsia
abdominal
pain
helicobacter
pylori
[C06.405.748.398]
[C06.405.748.586]
[C06.405.748.586.698]
[C06.405.748.586.849]
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain
timeFrame: 6 momths
Secondary outcomes:
measure: SES measures
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Washington
country: United States
facility: GWU Hospital
state: District of Columbia
Study officials:
References: