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

Peptic Ulcer Clinical Trial

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.)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376414
• Other study ID #: IRB#: 111050
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: August 24, 2016
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2012
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Pain
• Emergencies
• Gastritis
• Peptic Ulcer
• Peptic Ulcer Perforation
• Stomach Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	District of Columbia
United States	GWU Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	SES measures	DoeS SES correlate with HP infection?	6 months	No

External Links

•   Annals of Emergency Medicine Article