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

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.)

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.

Study Overview

• Status: Completed
• Conditions: Gastritis; Peptic Ulcer; Stomach Ulcer; Peptic Ulcer Perforation
• Intervention / Treatment: Other: Urea Breath Test (UBT) for H. pylori infection

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 Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
    • Washington, District of Columbia, United States, 20037
      • GWU Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non specific upper abdominal pain; 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.; Other Names: 13C; UBT; H. pylori; helicobacter; gastric; ulcers; dyspepsia; emergency; abdominal pain; exalenz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SES measures	DoeS SES correlate with HP infection?	6 months

Collaborators and Investigators

• Sponsor: George Washington University

Publications and helpful links

Helpful Links

• Annals of Emergency Medicine Article

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (ESTIMATE): June 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: pain; abdominal; dyspepsia; pylori; helicobacter; [C06.405.748.398]; [C06.405.748.586]; [C06.405.748.586.698]; [C06.405.748.586.849]
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Duodenal Diseases; Ulcer; Emergencies; Gastritis; Abdominal Pain; Stomach Ulcer; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: IRB#: 111050