Helicobacter Pylori InfectionPhase 3NCT02010112
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
A Phase 3 study testing Breath Test Collection bags in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 9 sites in United States.
Trial summary
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Breath Test Collection bags
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2014to Feb 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Present with clinical indication of H. pylori and candidate for upper endoscopy
- Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
- Naive to treatment in the past 18 months
- No known H.pylori status (no conclusive test results within last 6 months)
Who cannot join
- Participation in other interventional trials
- Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
- PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
- Pregnant or breastfeeding women
- Allergy to test substrates
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Digestive Disease Associates, PA
Baltimore, Maryland, 21229
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815
Henry Ford Health System
Detroit, Michigan, 48377
JM Research
Houston, Texas, 77011
Clinical Research Solutions
Jackson, Tennessee, 38305
Digestive Health Care
Ocean Springs, Mississippi, 39564
Bon Secours Health System
Richmond, Virginia, 23226
Montefiore Hospital
The Bronx, New York, 10467
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
Read the detailed description
This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Breath Test Collection bags
- Keywords
- H.Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Test Collection bagsOther
Also called IDKit Two
Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate
| Study group | Role | What they receive |
|---|---|---|
| Initial Diagnosis Cohort | Experimental | Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy Receives: Other: Breath Test Collection bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall percent agreement
The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.
Measured: 21 days
Secondary outcomes (1)
overall percent agreement
The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melina Arazy, M.D., Study director, VP of clinical affairs, Exalenz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010112
- Sponsor's protocol ID
- DM-MPBA-0813
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2013
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results
- ClinicalTrials.gov ID
- NCT02010112
- Acronym / sponsor ID
- DM-MPBA-0813
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H.Pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Dec 2013 (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.
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
Detailed description
This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Initial Diagnosis Cohort | Experimental | Other: Breath Test Collection bagsSubjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Present with clinical indication of H. pylori and candidate for upper endoscopy
- Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
- Naive to treatment in the past 18 months
- No known H.pylori status (no conclusive test results within last 6 months)
Key exclusion criteria (5 listed)
- Participation in other interventional trials
- Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
- PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
- Pregnant or breastfeeding women
- Allergy to test substrates
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 |
|---|---|---|
| Breath Test Collection bagsAlso: IDKit TwoBreath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate | Other | Initial Diagnosis Cohort |
Primary outcome
overall percent agreement
Time frame: 21 days
The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.
1 secondary outcome
overall percent agreement
Time frame: 21 days
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 20 Dec 2022.
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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.
Melina Arazy, M.D. study director
VP of clinical affairs, Exalenz
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breath Test Collection bags in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 9 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 4 inclusion and 5 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
overall percent agreement (time frame: 21 days). 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 20 Dec 2022.