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.)
1 other identifier
observational
212
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 26, 2016
August 1, 2012
3.4 years
June 16, 2011
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
SES measures
6 months
Study Arms (1)
Non specific upper abdominal pain
Cohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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?"
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
GWU Hospital
Washington D.C., District of Columbia, 20037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 20, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2014
Study Completion
March 1, 2015
Last Updated
August 26, 2016
Record last verified: 2012-08