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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01376414
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : August 26, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gastritis Peptic Ulcer Peptic Ulcer Perforation Stomach Ulcer 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
Actual Enrollment : 212 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : March 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

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

Primary Outcome Measures :
  1. Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain [ Time Frame: 6 momths ]
    Prevalence of H. pylori infection diagnosed by UBT in patients with symptomatic upper abdominal pain treated in the ED.

Secondary Outcome Measures :
  1. SES measures [ Time Frame: 6 months ]
    DoeS SES correlate with HP infection?

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01376414

United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
GWU Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University

Additional Information:
Responsible Party: George Washington University Identifier: NCT01376414     History of Changes
Other Study ID Numbers: IRB#: 111050
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2012

Keywords provided by George Washington University:

Additional relevant MeSH terms:
Abdominal Pain
Peptic Ulcer
Stomach Ulcer
Peptic Ulcer Perforation
Pathologic Processes
Disease Attributes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases