GastritisNCT02741414
A Multi-center Study for Eradication of Refractory Helicobacter Pylori
A study testing The result of H pylori culture based on gram staining and enzyme activity testing, The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole and The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing in people with Gastritis, run by Taizhou Hospital at 1 site in China.
Trial summary
Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. 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 result of H pylori culture based on gram staining and enzyme activity testing, The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole and The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,428 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2018
- 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 PPIs 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.
- Esophageal,gastrointestinal surgery history.
- Patients can not properly express their complaints,such as psychosis, severe neurosis.
- Taking nonsteroidal antiinflammatory drugs (NSAIDs) or alcohol abusers.
- Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xianju People Hospital
Taizhou, Zhejiang, 317300
Hong Li Lyh, 13586202668
About this study
Official title: Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies
Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. pylori is still existing, although patients have good compliance and receive standardized treatment. This phenomenon is likely attributed to the different ratio of sensitive and resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. In order to solve the refractory infection of H. pylori, investigators performed a muti-center study together with other 14 institutions. In this study, investigators will select the patients with refractory infection of H. pylori after two standardized treatment from patients with first eradication therapy of H. pylori infection. Then, investigators will perform a high-throughput sequencing for patients in groups. Finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.
- Conditions
- Gastritis
- Being tested
- The result of H pylori culture based on gram staining and enzyme activity testing, The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole, The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The result of H pylori culture based on gram staining and enzyme activity testingDevice
This intervention aimed at patients with the positive result of 13C-urea breath test. Patients with negative result of H pylori culture was H pylori culture negative group. Patients with positive result of H pylori culture were belonged into the first successful eradication group and the refractory infection of H. pylori group.
The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazoleDevice
The intervention focused on the results from the result of 13C-urea breath test after treatment. The first successful eradication group and the refractory infection of H. pylori group were treated according to the antibiotic susceptibility testing and CYP2C19 gene polymorphism. Eight weeks after treatment, a 13C-urea breath test was performed on patients. The first successful eradication group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients with positive in 13C-urea breath tests after the second standardized treatment.
The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testingDevice
The intervention focused on the results from the result of Amoxicillin susceptibility testing in vitro. In this study, the investigators selected the patients with Amoxicillin resistance from the first successful eradication group and the refractory infection of H. pylori group.
| Study group | Role | What they receive |
|---|---|---|
| H pylori culture negative group | Experimental | The patients who have the negative result of H pylori culture were classified into H pylori culture negative group. Receives: Device: The result of H pylori culture based on gram staining and enzyme activity testing |
| The first successful eradication group | Experimental | The patients with first eradication therapy of H. pylori infection have the first successful treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and proton pump inhibitors （PPIs) dose selection from CYP2C19 gene sequencing. Receives: Device: The result of H pylori culture based on gram staining and enzyme activity testing; Device: The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole; Device: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing |
| The refractory infection of H. pylori group | Experimental | The patients with first eradication therapy of H. pylori infection have the two failure treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and PPIs dose selection from CYP2C19 gene sequencing. Receives: Device: The result of H pylori culture based on gram staining and enzyme activity testing; Device: The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole; Device: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of H. pylori reach to 95% in all groups
Measured: 1 year
The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group
Measured: Three months
The proportion of mix infection of H pylori in a total of 240 patients in two groups
Measured: Three months
The number of single nucleotide varation（SNV）of 20 patients in the first successful eradication group and the refractory infection of H. pylori group that are related to Amoxicillin resistance
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (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
- 4,428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China, Academy Military Medical Science, China, First Affiliated Hospital of Zhejiang University, Taizhou Enze Medical Center Group, Taizhou First People's Hospital, The first people Hospital of Linhai, Affiliated Wenling Hospital of Wenzhou Medical University, Sanmen People Hospital, Xianju People's Hospital, Tiantai County People's Hospital, Yuhuan People Hospital, The second people Hospital of Yuhuan, Zhiyuan Medical Inspection Institute
- Responsible party
- Principal investigator, Liping Ye, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741414
- Sponsor's protocol ID
- TaizhouH
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies
- ClinicalTrials.gov ID
- NCT02741414
- Acronym / sponsor ID
- TaizhouH
- Conditions
- Gastritis
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,428 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China, Academy Military Medical Science, China, First Affiliated Hospital of Zhejiang University, Taizhou Enze Medical Center Group, Taizhou First People's Hospital, The first people Hospital of Linhai, Affiliated Wenling Hospital of Wenzhou Medical University, Sanmen People Hospital, Xianju People's Hospital, Tiantai County People's Hospital, Yuhuan People Hospital, The second people Hospital of Yuhuan, Zhiyuan Medical Inspection Institute
- Study start
- Jun 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Apr 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.
Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. pylori is still existing, although patients have good compliance and receive standardized treatment. This phenomenon is likely attributed to the different ratio of sensitive and resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. In order to solve the refractory infection of H. pylori, investigators performed a muti-center study together with other 14 institutions. In this study, investigators will select the patients with refractory infection of H. pylori after two standardized treatment from patients with first eradication therapy of H. pylori infection. Then, investigators will perform a high-throughput sequencing for patients in groups. Finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H pylori culture negative group | Experimental | Device: The result of H pylori culture based on gram staining and enzyme activity testingThe patients who have the negative result of H pylori culture were classified into H pylori culture negative group. |
| The first successful eradication group | Experimental | Device: The result of H pylori culture based on gram staining and enzyme activity testing, Device: The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole, Device: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testingThe patients with first eradication therapy of H. pylori infection have the first successful treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and proton pump inhibitors （PPIs) dose selection from CYP2C19 gene sequencing. |
| The refractory infection of H. pylori group | Experimental | Device: The result of H pylori culture based on gram staining and enzyme activity testing, Device: The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole, Device: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testingThe patients with first eradication therapy of H. pylori infection have the two failure treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and PPIs dose selection from CYP2C19 gene sequencing. |
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 PPIs 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 (7 listed)
- Severe heart, liver, kidney dysfunction.
- Pregnant or lactating women.
- Complications of bleeding, perforation, pyloric obstruction, cancer.
- Esophageal,gastrointestinal surgery history.
- Patients can not properly express their complaints,such as psychosis, severe neurosis.
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 result of H pylori culture based on gram staining and enzyme activity testingThis intervention aimed at patients with the positive result of 13C-urea breath test. Patients with negative result of H pylori culture was H pylori culture negative group. Patients with positive result of H pylori culture were belonged into the first successful eradication group and the refractory infection of H. pylori group. | Device | H pylori culture negative group, The first successful eradication group, The refractory infection of H. pylori group |
| The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazoleThe intervention focused on the results from the result of 13C-urea breath test after treatment. The first successful eradication group and the refractory infection of H. pylori group were treated according to the antibiotic susceptibility testing and CYP2C19 gene polymorphism. Eight weeks after treatment, a 13C-urea breath test was performed on patients. The first successful eradication group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients with positive in 13C-urea breath tests after the second standardized treatment. | Device | The first successful eradication group, The refractory infection of H. pylori group |
| The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testingThe intervention focused on the results from the result of Amoxicillin susceptibility testing in vitro. In this study, the investigators selected the patients with Amoxicillin resistance from the first successful eradication group and the refractory infection of H. pylori group. | Device | The first successful eradication group, The refractory infection of H. pylori group |
Primary outcome
The eradication rate of H. pylori reach to 95% in all groups
Time frame: 1 year
The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group
Time frame: Three months
The proportion of mix infection of H pylori in a total of 240 patients in two groups
Time frame: Three months
The number of single nucleotide varation（SNV）of 20 patients in the first successful eradication group and the refractory infection of H. pylori group that are related to Amoxicillin resistance
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
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 result of H pylori culture based on gram staining and enzyme activity testing, The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole and The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing in people with Gastritis, run by Taizhou 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 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. 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 Liping Ye, BSc (13566866269, yelp@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eradication rate of H. pylori reach to 95% in all groups (time frame: 1 year). The study lists 4 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 12 Jul 2016.