Helicobacter Pylori InfectionPhase 3NCT02905825
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
A Phase 3 study testing BreathID® Hp System, BreathID® Hp Lab System and Stool Test in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 6 sites in 2 countries.
Trial summary
Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- BreathID® Hp System, BreathID® Hp Lab System and Stool Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 May 2017to 5 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be older than 3 and younger than 18 years of age
- Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
- Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
- Naïve to H. pylori treatment in the past 6 weeks
Who cannot join
- Participation in other interventional trials
- PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
- Pregnant or breastfeeding female
- Allergy to test substrates
- Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
- Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
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- Exposure to any 13C-enriched substance 24 hours prior to the breath test.
- Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
- Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Children's Health - Children's Medical Center Dallas (UT Southwestern)
Dallas, Texas, 75235
Gastrointestinal Associates
Flowood, Mississippi, 39232
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77094
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 10238
Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
Shreveport, Louisiana, 71118
About this study
Official title: Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Read the detailed description
Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- BreathID® Hp System, BreathID® Hp Lab System, Stool Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreathID® Hp SystemDevice
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
BreathID® Hp Lab SystemDrug
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
Stool TestDiagnostic test
Also called Stool Antigen Test
Each subject was asked to perform a stool test in parallel to the breath test.
| Study group | Role | What they receive |
|---|---|---|
| Indication for Helicobacter pylori testing | Experimental | Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. Receives: Device: BreathID® Hp System; Drug: BreathID® Hp Lab System; Diagnostic Test: Stool Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reported Adverse Events
Number of participants with reported adverse events after performing urea breath test
Measured: 24 hours
Secondary outcomes (2)
Percentage of Agreement
Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection
Measured: 1 week
Percentage of Agreement
Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start18 May 2017
- Primary completion30 Oct 2017
- Study completion5 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905825
- Sponsor's protocol ID
- PED-HP-0616B
- Status last verified
- Jun 2018
- First submitted
- 6 Sep 2016
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- 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 Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
- ClinicalTrials.gov ID
- NCT02905825
- Acronym / sponsor ID
- PED-HP-0616B
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 5 Nov 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Detailed description
Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
| Arm | Type | Receives |
|---|---|---|
| Indication for Helicobacter pylori testing | Experimental | Device: BreathID® Hp System, Drug: BreathID® Hp Lab System, Diagnostic Test: Stool TestWalk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be older than 3 and younger than 18 years of age
- Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
- Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
- Naïve to H. pylori treatment in the past 6 weeks
Key exclusion criteria (9 listed)
- Participation in other interventional trials
- PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
- Pregnant or breastfeeding female
- Allergy to test substrates
- Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
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 |
|---|---|---|
| BreathID® Hp SystemBreath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea | Device | Indication for Helicobacter pylori testing |
| BreathID® Hp Lab SystemBreath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea | Drug | Indication for Helicobacter pylori testing |
| Stool TestAlso: Stool Antigen TestEach subject was asked to perform a stool test in parallel to the breath test. | Diagnostic test | Indication for Helicobacter pylori testing |
Primary outcome
Number of Participants With Reported Adverse Events
Time frame: 24 hours
Number of participants with reported adverse events after performing urea breath test
2 secondary outcomes
Percentage of Agreement
Time frame: 1 week
Percentage of Agreement
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BreathID® Hp System, BreathID® Hp Lab System and Stool Test in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 6 sites in 2 countries.
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 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 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 6 sites in United States, Israel. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Reported Adverse Events (time frame: 24 hours). 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.