Helicobacter InfectionsPhase 2NCT00194688
Breath Ammonia Method for H. Pylori Detection: Phase II
A Phase 2 study testing H. pylori treatment in people with Helicobacter Infections, run by University of Washington at 1 site in United States.
Trial summary
The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- H. pylori treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jun 2005
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers not meeting exclusion criteria
Who cannot join
- Known cirrhosis of the liver
- Renal insufficiency (BUN greater than 40 mg/dl, Creatinine greater than 2.0 mg/dl).
- Prior gastric resection
- Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second less than 1.5 L)
- Patients unwilling or unable to discontinue proton pump inhibitors for 2 weeks prior to scheduled 14C or non-isotopic urea breath testing
- Patients who have received antibiotics or bismuth within the preceding month.
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- Patients unwilling or unable to give informed consent
- Pregnant women (14C urea breath test is not approved for use in pregnant women)
- Age less than 21 years (14C urea breath test is not approved for use in children)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
Read the detailed description
Healthy volunteers will undergo testing for H. pylori infection using a 14-C urea breath test, and the results will be compared to an experimental ammonia breath test. The breath sample will be collected by an investigational device that the patient will be exposed to consisting of a plastic mouth-piece which is attached to a T-tubing section having a side-arm port through which a fiberoptic ammonia sensor is inserted inside the tube. To meet the Phase II specific aim, the scope of the clinical trials is expanded addressing the following specific objectives:
- Test refinements of the sensing system (hardware, software, \& breath test device)
- Determine whether a urea dose-response effect exists following urea ingestion,
- Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H. pylori infected vs. uninfected persons.
- Determine the appropriate time interval for breath ammonia testing following urea ingestion.
- Determine whether there is a change in breath ammonia level after H. pylori treatment.
- Conditions
- Helicobacter Infections
- Being tested
- H. pylori treatment
- Keywords
- ammonia
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H. pylori treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of breath ammonia measurement for H. pylori infection
Secondary outcomes (2)
Determination of a dose response relationship for oral urea dose and breath ammonia level.
Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 278 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- David L Putnam, PhD, Study director, Pacific Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194688
- Sponsor's protocol ID
- 01-8470-V 04
- Other IDs
- 2R44DK055935-02
- Status last verified
- Jan 2008
- First submitted
- 13 Sep 2005
- Last updated
- 11 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Ammonia Method for H. Pylori Detection: Phase II
- ClinicalTrials.gov ID
- NCT00194688
- Acronym / sponsor ID
- 01-8470-V 04
- Conditions
- Helicobacter Infections
- Keywords
- ammonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2003
- Study completion
- Jun 2005
- First posted
- 19 Sep 2005 (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.
The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
Detailed description
Healthy volunteers will undergo testing for H. pylori infection using a 14-C urea breath test, and the results will be compared to an experimental ammonia breath test. The breath sample will be collected by an investigational device that the patient will be exposed to consisting of a plastic mouth-piece which is attached to a T-tubing section having a side-arm port through which a fiberoptic ammonia sensor is inserted inside the tube. To meet the Phase II specific aim, the scope of the clinical trials is expanded addressing the following specific objectives:
- Test refinements of the sensing system (hardware, software, \& breath test device)
- Determine whether a urea dose-response effect exists following urea ingestion,
- Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H. pylori infected vs. uninfected persons.
- Determine the appropriate time interval for breath ammonia testing following urea ingestion.
- Determine whether there is a change in breath ammonia level after H. pylori treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult volunteers not meeting exclusion criteria
Key exclusion criteria (9 listed)
- Known cirrhosis of the liver
- Renal insufficiency (BUN greater than 40 mg/dl, Creatinine greater than 2.0 mg/dl).
- Prior gastric resection
- Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second less than 1.5 L)
- Patients unwilling or unable to discontinue proton pump inhibitors for 2 weeks prior to scheduled 14C or non-isotopic urea breath testing
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 |
|---|---|---|
| H. pylori treatment | Drug | – |
Primary outcome
Sensitivity and specificity of breath ammonia measurement for H. pylori infection
2 secondary outcomes
Determination of a dose response relationship for oral urea dose and breath ammonia level.
Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment.
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 11 Jan 2008.
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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.
David L Putnam, PhD study director
Pacific Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H. pylori treatment in people with Helicobacter Infections, run by University of Washington at 1 site 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 9 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 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sensitivity and specificity of breath ammonia measurement for H. pylori infection. 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 11 Jan 2008.