GastritisNCT02923856
A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin
A study testing The results of clarithromycin susceptibility test of H. pylori isolates, Computer generated random number, randomly assigned into groups and The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups in people with Gastritis, run by Sanmen People's Hospital at 1 site in China.
Trial summary
As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastritis
- What is being tested?
- The results of clarithromycin susceptibility test of H. pylori isolates, Computer generated random number, randomly assigned into groups and The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
- Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- 13C-labelled urea breath test positive.
- Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
Who cannot join
- Severe heart, liver, kidney dysfunction.
- Pregnant or lactating women.
- Complications of bleeding, perforation, pyloric obstruction, cancer.
- Within 3 months before with the drugs involved in other drugs research.
- Esophageal,gastrointestinal surgery history.
- Patients can not properly express their complaints,such as psychosis, severe neurosis.
- Taking NSIAD or alcohol abusers.
- Allergic to amoxicillin or clarithromycin tested by susceptibility testing.
Trial locations and contacts
1 site in 1 country.
zhang hong Li, doctor contact
China1 site, 1 recruiting
- Recruiting
Sanmen People's hospital
Taizhou, Zhejiang, 317199
zhang hong Li, doctor, smyylhz@163.com
About this study
Official title: A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Based on Accurate Susceptibility Testing of Clarithromycin
As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.
- Conditions
- Gastritis
- Being tested
- The results of clarithromycin susceptibility test of H. pylori isolates, Computer generated random number, randomly assigned into groups, The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The results of clarithromycin susceptibility test of H. pylori isolatesDevice
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groupsDevice
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsDevice
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin resistance group | Experimental | Patients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates |
| 7 days Successful treatment | Experimental | The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups |
| 7 days failed treatment | Experimental | The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups |
| 10 days Successful treatment | Experimental | The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups |
| 10 days failed treatment | Experimental | The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups |
| 14 days Successful treatment | Experimental | The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups |
| 14 days failed treatment | Experimental | The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment. Receives: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accurate determination of clarithromycin susceptibility.
Assess bacterial susceptibility to antibiotics using the agar diffusion method. The Resistance point of clarithromycin was divided into 0.125μg/ml,0.25μg/ml,0.5μg/ml and 1μg/ml.Test clarithromycin resistance of Helicobacter pylori for patients.
Measured: 2 years
Establish individualized precision triple therapy based on minimal inhibitory concentration.
Based on the clarithromycin accurate susceptibility，pinpoint different courses of triple treatment therapy targeted to different people based on minimal inhibitory concentration of clarithromycin.
Measured: 2.5 years
Secondary outcomes (1)
The incidence of adverse effects
Drugs targeted, it could reduce the intake of antibiotics for patients.The incidence of adverse effects in the eradicate treatment will reduce. Avoid patients' unnecessary economic losses.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanmen People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Central Hospital, The First Affiliated Hospital with Nanjing Medical University, Taizhou Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, Hangzhou Medical College, Centers for Disease Control and Prevention, China, Zhiyuan Medical Inspection Institute
- Responsible party
- Principal investigator, Hongzhang Li, Sanmen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923856
- Sponsor's protocol ID
- SanmenPH
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Based on Accurate Susceptibility Testing of Clarithromycin
- ClinicalTrials.gov ID
- NCT02923856
- Acronym / sponsor ID
- SanmenPH
- Conditions
- Gastritis
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- Sanmen People's HospitalUniversity, hospital or other
- Collaborators
- Wenzhou Central Hospital, The First Affiliated Hospital with Nanjing Medical University, Taizhou Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, Hangzhou Medical College, Centers for Disease Control and Prevention, China, Zhiyuan Medical Inspection Institute
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Oct 2016 (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.
As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin resistance group | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolatesPatients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group. |
| 7 days Successful treatment | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolates, Device: Computer generated random number, randomly assigned into groups, Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment. |
| 7 days failed treatment | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolates, Device: Computer generated random number, randomly assigned into groups, Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment. |
| 10 days Successful treatment | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolates, Device: Computer generated random number, randomly assigned into groups, Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment. |
| 10 days failed treatment | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolates, Device: Computer generated random number, randomly assigned into groups, Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment. |
| 14 days Successful treatment | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolates, Device: Computer generated random number, randomly assigned into groups, Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment. |
| 14 days failed treatment | Experimental | Device: The results of clarithromycin susceptibility test of H. pylori isolates, Device: Computer generated random number, randomly assigned into groups, Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
- Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- 13C-labelled urea breath test positive.
- Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
Key exclusion criteria (8 listed)
- Severe heart, liver, kidney dysfunction.
- Pregnant or lactating women.
- Complications of bleeding, perforation, pyloric obstruction, cancer.
- Within 3 months before with the drugs involved in other drugs research.
- Esophageal,gastrointestinal surgery history.
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 |
|---|---|---|
| The results of clarithromycin susceptibility test of H. pylori isolatesAccording to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups. | Device | 10 days Successful treatment, 10 days failed treatment, 14 days Successful treatment, 14 days failed treatment, 7 days Successful treatment, 7 days failed treatment, Clarithromycin resistance group |
| Computer generated random number, randomly assigned into groupsThe patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups. | Device | 10 days Successful treatment, 10 days failed treatment, 14 days Successful treatment, 14 days failed treatment, 7 days Successful treatment, 7 days failed treatment |
| The result of 13C-urea breath test of patient in 7days/10days/14days treatment groupsThe intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment. | Device | 10 days Successful treatment, 10 days failed treatment, 14 days Successful treatment, 14 days failed treatment, 7 days Successful treatment, 7 days failed treatment |
Primary outcome
The accurate determination of clarithromycin susceptibility.
Time frame: 2 years
Assess bacterial susceptibility to antibiotics using the agar diffusion method. The Resistance point of clarithromycin was divided into 0.125μg/ml,0.25μg/ml,0.5μg/ml and 1μg/ml.Test clarithromycin resistance of Helicobacter pylori for patients.
Establish individualized precision triple therapy based on minimal inhibitory concentration.
Time frame: 2.5 years
Based on the clarithromycin accurate susceptibility，pinpoint different courses of triple treatment therapy targeted to different people based on minimal inhibitory concentration of clarithromycin.
1 secondary outcome
The incidence of adverse effects
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
zhang hong Li, doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The results of clarithromycin susceptibility test of H. pylori isolates, Computer generated random number, randomly assigned into groups and The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups in people with Gastritis, run by Sanmen People's Hospital 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang hong Li, doctor (smyylhz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accurate determination of clarithromycin susceptibility. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 19 Feb 2019.