GastritisNCT01376414
H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department
An observational study of Gastritis and Peptic Ulcer, run by George Washington University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastritis, Peptic Ulcer, Peptic Ulcer Perforation
- What is being tested?
- Urea Breath Test (UBT) for H. pylori infection
- How many people
- 212 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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?"
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
George Washington University Hospital
Washington D.C., District of Columbia, 20037
GWU Hospital
Washington D.C., District of Columbia, 20037
About this study
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.)
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.
Read the 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.
- Conditions
- Gastritis, Peptic Ulcer, Peptic Ulcer Perforation, Stomach Ulcer
- Being tested
- Urea Breath Test (UBT) for H. pylori infection
- Keywords
- dyspepsia, abdominal, pain, helicobacter, pylori, [C06.405.748.398], [C06.405.748.586], [C06.405.748.586.698], [C06.405.748.586.849]
- Medical subject headings
- Gastritis, Peptic Ulcer, Peptic Ulcer Perforation, Stomach Ulcer, Dyspepsia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urea Breath Test (UBT) for H. pylori infectionOther
Also called 13C, UBT, H. pylori, helicobacter
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.
| Study group | Role | What they receive |
|---|---|---|
| Non specific upper abdominal pain | Cohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause. Receives: Other: Urea Breath Test (UBT) for H. pylori infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 momths
Secondary outcomes (1)
SES measures
DoeS SES correlate with HP infection?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376414
- Sponsor's protocol ID
- IRB#: 111050
- Status last verified
- Aug 2012
- First submitted
- 16 Jun 2011
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.)
- ClinicalTrials.gov ID
- NCT01376414
- Acronym / sponsor ID
- IRB#: 111050
- Conditions
- Gastritis, Peptic Ulcer, Peptic Ulcer Perforation, Stomach Ulcer
- Keywords
- dyspepsia, abdominal, pain, helicobacter, pylori, [C06.405.748.398], [C06.405.748.586], [C06.405.748.586.698]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non specific upper abdominal pain | – | Other: Urea Breath Test (UBT) for H. pylori infectionCohort is patients who present to the Emergency Department with primary complaint of upper abdominal pain without obvious cause. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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?"
Key exclusion criteria (10 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urea Breath Test (UBT) for H. pylori infectionAlso: 13C, UBT, H. pylori, helicobacter13C 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 | Non specific upper abdominal pain |
Primary outcome
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.
1 secondary outcome
SES measures
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastritis and Peptic Ulcer, run by George Washington University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain (time frame: 6 momths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.