Oral Helicobacter PyloriPhase 1/2NCT01863823
The Effective Treatment of Oral Helicobacter Pylori With the Success Rate of Gastric Eradication
A Phase 1/2 study testing Amoxicillin and Tetracyclines and Mouth washing in people with Oral Helicobacter Pylori, run by Ameritek USA at 1 site in China.
Trial summary
1. Gastric eradication has no effective on oral H. pylori infection. 2. Treatment of oral infection increase success rate of eradication on stomach infection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Helicobacter Pylori
- What is being tested?
- Amoxicillin and Tetracyclines and Mouth washing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with gastrointestinal complaints
Who cannot join
- patients who had taken any antibiotics and/or proton pump inhibitors within four weeks prior to sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Director of Research Division
- Gastric eradication has no effective on oral H. pylori infection.
- Treatment of oral infection increase success rate of eradication on stomach infection.
Read the detailed description
Objective: The present study was aimed to explore the relationship of Helicobacter pylori(H. pylori) of the oral cavity with the success rate eradication of gastric H. pylori infection.
Study Design and Setting: 202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.
We collected data of HPS, HPF , PCR and UBT before treatment on 202 symptomatic patients and 148 asymptomatic individual groups. After drug treatment, we run HPS, HPF, PCR and UBT tests. If the tests of HPS, HPF and PCR show negative that indicate success of oral H.pylori eradication. If the test of UBT show negative that indicate success of stomach H.pyloi eradication. We also compare the suceess rate of eradication on stomach infection with and without oral H. pylori infection.
- Conditions
- Oral Helicobacter Pylori
- Being tested
- Amoxicillin and Tetracyclines, Mouth washing
- Keywords
- Symptomatic patients, asymptomatic individuals, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin and TetracyclinesDrug
Also called dBest
202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.
Mouth washingDrug
Also called dBest
Two time washing mouth per day
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin and Tetracyclines | Other | drug treatment Receives: Drug: Amoxicillin and Tetracyclines |
| Mouth washing | Other | Mouth washing Receives: Drug: Mouth washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Measured: 12 months
Secondary outcomes (1)
Diagnostic
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ameritek USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, K C Yee, Ameritek USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863823
- Sponsor's protocol ID
- AmeritekUsa
- Other IDs
- Ameritek USA
- Status last verified
- May 2013
- First submitted
- 10 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang XM, Yee KC, Hazeki-Taylor N, Li J, Fu HY, Huang ML, Zhang GY. Oral Helicobacter pylori, its relationship to successful eradication of gastric H. pylori and saliva culture confirmation. J Physiol Pharmacol. 2014 Aug;65(4):559-66.
PubMed 25179088
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director of Research Division
- ClinicalTrials.gov ID
- NCT01863823
- Acronym / sponsor ID
- AmeritekUsa
- Conditions
- Oral Helicobacter Pylori
- Keywords
- Symptomatic patients, asymptomatic individuals, clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ameritek USAIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 May 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.
- Gastric eradication has no effective on oral H. pylori infection.
- Treatment of oral infection increase success rate of eradication on stomach infection.
Detailed description
Objective: The present study was aimed to explore the relationship of Helicobacter pylori(H. pylori) of the oral cavity with the success rate eradication of gastric H. pylori infection.
Study Design and Setting: 202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.
We collected data of HPS, HPF , PCR and UBT before treatment on 202 symptomatic patients and 148 asymptomatic individual groups. After drug treatment, we run HPS, HPF, PCR and UBT tests. If the tests of HPS, HPF and PCR show negative that indicate success of oral H.pylori eradication. If the test of UBT show negative that indicate success of stomach H.pyloi eradication. We also compare the suceess rate of eradication on stomach infection with and without oral H. pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin and Tetracyclines | Other | Drug: Amoxicillin and Tetracyclinesdrug treatment |
| Mouth washing | Other | Drug: Mouth washingMouth washing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with gastrointestinal complaints
Key exclusion criteria (1 listed)
- patients who had taken any antibiotics and/or proton pump inhibitors within four weeks prior to sample collection
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 |
|---|---|---|
| Amoxicillin and TetracyclinesAlso: dBest202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments. | Drug | Amoxicillin and Tetracyclines |
| Mouth washingAlso: dBestTwo time washing mouth per day | Drug | Mouth washing |
Primary outcome
Success Rate
Time frame: 12 months
1 secondary outcome
Diagnostic
Time frame: 6 months
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 29 May 2013.
- Derived from this study: PubMed 25179088Wang XM, Yee KC, Hazeki-Taylor N, Li J, Fu HY, Huang ML, Zhang GY. Oral Helicobacter pylori, its relationship to successful eradication of gastric H. pylori and saliva culture confirmation. J Physiol Pharmacol. 2014 Aug;65(4):559-66.
Related trials for Oral Helicobacter Pylori
Active, not recruiting
Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM)
Achalasia Cardia, GERD (Gastroesophageal Reflux Disease)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amoxicillin and Tetracyclines and Mouth washing in people with Oral Helicobacter Pylori, run by Ameritek USA at 1 site in China.
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 1 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 29 May 2013. 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 China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Success Rate (time frame: 12 months). 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 NCT01863823, 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 29 May 2013.