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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01376414
First received: June 16, 2011
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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 Intervention
Gastritis
Peptic Ulcer
Peptic Ulcer Perforation
Stomach Ulcer
Other: Urea Breath Test (UBT) for H. pylori infection

Study Type: Observational
Study Design: 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.)

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain [ Time Frame: 6 momths ] [ Designated as safety issue: No ]
    Prevalence of H. pylori infection diagnosed by UBT in patients with symptomatic upper abdominal pain treated in the ED.


Secondary Outcome Measures:
  • SES measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DoeS SES correlate with HP infection?


Estimated Enrollment: 250
Study Start Date: March 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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 [pantoparazole], prevacid [lansoprazole], aciphex [raeprazole], 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376414

Locations
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
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01376414     History of Changes
Other Study ID Numbers: IRB#: 111050
Study First Received: June 16, 2011
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
dyspepsia
abdominal
pain
helicobacter
pylori
[C06.405.748.398]
[C06.405.748.586]
[C06.405.748.586.698]
[C06.405.748.586.849]

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

ClinicalTrials.gov processed this record on November 25, 2014