Helicobacter PyloriPhase 3NCT05276557
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
A Phase 3 study testing PyloPlus Urea Breath Test System and Stool Antigen Test in people with Helicobacter Pylori and Safety, run by ARJ Medical, Inc. at 3 sites in United States.
Trial summary
This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori, Safety, Efficacy
- What is being tested?
- PyloPlus Urea Breath Test System and Stool Antigen Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Nov 2022to Jun 2023
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female age 3-17 at the time of visit
- Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
- Naive to H. pylori treatment in the past 4 weeks
Who cannot join
- Pregnant and/or lactating women
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
- Participation in other interventional trials
- Allergy to test substrates
- Antibiotics taken within 4 weeks of the testing
- Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food
- Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Dolphin Medical Research
Doral, Florida, 33172
Fermin Nieto, 305-870-5999
Inosvani Barraso, MD
- Recruiting
Harmony United Research
El Paso, Texas, 79902
Arthur Imai, 915-519-5297
Miguel Gutierrez, 915-706-9902
- Recruiting
Orlando Health, Inc.
Orlando, Florida, 32806
Yazandra Parrimon, RN
Jeffrey Bornstein, MD
About this study
This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.
Centers will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.
Read more
Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.
Total duration of study is anticipated to be approximately 6 months.
- Conditions
- Helicobacter Pylori, Safety, Efficacy
- Being tested
- PyloPlus Urea Breath Test System, Stool Antigen Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyloPlus Urea Breath Test SystemCombination product
System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.
Stool Antigen TestDiagnostic test
An antigen test performed via a laboratory to test patients' stool for H. pylori
| Study group | Role | What they receive |
|---|---|---|
| Indication for H. pylori testing | Experimental | Walk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison. Receives: Combination Product: PyloPlus Urea Breath Test System; Diagnostic Test: Stool Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recorded adverse events
Number of participants with recorded adverse events after performing urea breath test
Measured: 24 hours
Secondary outcomes (1)
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: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start17 Nov 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARJ Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276557
- Sponsor's protocol ID
- ARJ-2022-PED
- Status last verified
- May 2023
- First submitted
- 3 Mar 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT05276557
- Acronym / sponsor ID
- ARJ-2022-PED
- Conditions
- Helicobacter Pylori, Safety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ARJ Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Mar 2022 (actual)
- 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 is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.
Centers will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.
Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.
Total duration of study is anticipated to be approximately 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indication for H. pylori testing | Experimental | Combination Product: PyloPlus Urea Breath Test System, Diagnostic Test: Stool Antigen TestWalk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female age 3-17 at the time of visit
- Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
- Naive to H. pylori treatment in the past 4 weeks
Key exclusion criteria (7 listed)
- Pregnant and/or lactating women
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
- Participation in other interventional trials
- Allergy to test substrates
- Antibiotics taken within 4 weeks of the 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 |
|---|---|---|
| PyloPlus Urea Breath Test SystemSystem containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion. | Combination product | Indication for H. pylori testing |
| Stool Antigen TestAn antigen test performed via a laboratory to test patients' stool for H. pylori | Diagnostic test | Indication for H. pylori testing |
Primary outcome
Number of participants with recorded adverse events
Time frame: 24 hours
Number of participants with recorded adverse events after performing urea breath test
1 secondary outcome
Percentage of Agreement
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
3 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 PyloPlus Urea Breath Test System and Stool Antigen Test in people with Helicobacter Pylori and Safety, run by ARJ Medical, Inc. at 3 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (877-855-4100, info@gulfcoastscientific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recorded 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 6 May 2023.