Helicobacter Pylori InfectionPhase 4NCT00825630
13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
A Phase 4 study testing Lansoprazole (Lanton), Omeprezole (Losec) and Esomeprazole (Nexium) in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 1 site in Israel.
Trial summary
Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. 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?
- Lansoprazole (Lanton), Omeprezole (Losec) and Esomeprazole (Nexium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Nov 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with H.pylori infection.
Who cannot join
- Pregnancy,
- Nursing,
- Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
- Known sensitivity to Urea or citrica.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.
Read the detailed description
Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.
- Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.
- Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lansoprazole (Lanton), Omeprezole (Losec), Pantoprazole(Controloc), Esomeprazole (Nexium)
- Keywords
- HP, UBT, PPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole (Lanton)Drug
Also called Lanton
Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
Omeprezole (Losec)Drug
Also called Losec
Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
Pantoprazole(Controloc)Drug
Also called Controloc
Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
Esomeprazole (Nexium)Drug
Also called Nexium
Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole (Lanton) | Active comparator | Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning Receives: Drug: Lansoprazole (Lanton) |
| Omeprazole (Losec) | Active comparator | Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning Receives: Drug: Omeprezole (Losec) |
| Pantoprazole (Controloc) | Active comparator | Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning Receives: Drug: Pantoprazole(Controloc) |
| Esomeprazole(Nexium) | Active comparator | Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning Receives: Drug: Esomeprazole (Nexium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rabin Medical Center
- Responsible party
- Sponsor
- Investigators
- Haim Shirin, MD, Principal investigator, Sharon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825630
- Sponsor's protocol ID
- HP-BID 608
- Status last verified
- Dec 2022
- First submitted
- 19 Jan 2009
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y. Effect of proton pump inhibitors on the continuous real time (13)C-urea breath test. Am J Gastroenterol. 2003 Jan;98(1):46-50. doi: 10.1111/j.1572-0241.2003.07187.x.
PubMed 12526935
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
- The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
- ClinicalTrials.gov ID
- NCT00825630
- Acronym / sponsor ID
- HP-BID 608
- Conditions
- Helicobacter Pylori Infection
- Keywords
- HP, UBT, PPI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rabin Medical Center
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 7 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.
Detailed description
Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.
- Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.
- Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole (Lanton) | Active comparator | Drug: Lansoprazole (Lanton)Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning |
| Omeprazole (Losec) | Active comparator | Drug: Omeprezole (Losec)Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning |
| Pantoprazole (Controloc) | Active comparator | Drug: Pantoprazole(Controloc)Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning |
| Esomeprazole(Nexium) | Active comparator | Drug: Esomeprazole (Nexium)Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with H.pylori infection.
Key exclusion criteria (4 listed)
- Pregnancy,
- Nursing,
- Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
- Known sensitivity to Urea or citrica.
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 |
|---|---|---|
| Lansoprazole (Lanton)Also: LantonOral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection | Drug | Lansoprazole (Lanton) |
| Omeprezole (Losec)Also: LosecOral administration of Omeprazole for 14 days in 25 patients with H.pylori infection | Drug | Omeprazole (Losec) |
| Pantoprazole(Controloc)Also: ControlocOral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection | Drug | Pantoprazole (Controloc) |
| Esomeprazole (Nexium)Also: NexiumOral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection | Drug | Esomeprazole(Nexium) |
Primary outcome
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
Time frame: 17 days
Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.
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.
- Results publication: PubMed 12526935Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y. Effect of proton pump inhibitors on the continuous real time (13)C-urea breath test. Am J Gastroenterol. 2003 Jan;98(1):46-50. doi: 10.1111/j.1572-0241.2003.07187.x.
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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.
Haim Shirin, MD principal investigator
Sharon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole (Lanton), Omeprezole (Losec) and Esomeprazole (Nexium) in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 1 site in Israel.
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 4 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 1 site in 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Oct 2011). 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?
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825630, which also lists 1 linked publication.
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.