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Completed

NCT Number: NCT01376414

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GWU Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Urea Breath Test (UBT) for H. pylori infection

Other

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 outcomes

  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 outcomes

  1. SES measures

    Time frame: 6 months

    DoeS SES correlate with HP infection?

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study 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.)

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2011
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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