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

Completed

• Conditions: Peptic Ulcer Perforation; Gastritis; Peptic Ulcer; Stomach Ulcer
• Interventions: Other: Urea Breath Test (UBT) for H. pylori infection

• Registration Number: NCT01376414
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Status Verified: 2012-08
• Primary Completion: 2014-08
• Study Completion: 2015-03
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non specific upper abdominal pain	Urea Breath Test (UBT) for H. pylori infection	Cohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
SES measures	6 months	DoeS SES correlate with HP infection?

Trial Locations

Locations (2)

GWU Hospital; 🇺🇸 Washington, District of Columbia, United States

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States