GastritisNCT02689583
A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection
A study testing Antibiotic selection based on the antibiotic susceptibility testing, PPI selection based on the CYP2C19 gene polymorphism and Probiotics usage based on the 16SrRNA sequencing in people with Gastritis and Gastric Ulcer, run by First Affiliated Hospital of Zhejiang University.
Trial summary
Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out with the goal of improving H. pylori eradication and therapies have changed from single-antibiotic treatments to the current multi-antibiotic treatments. However, the eradication rate of H. pylori is still less than 80%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastritis, Gastric Ulcer
- What is being tested?
- Antibiotic selection based on the antibiotic susceptibility testing, PPI selection based on the CYP2C19 gene polymorphism and Probiotics usage based on the 16SrRNA sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- 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, untreated patients.
- Symptoms of abdominal pain, bloating, acid reflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks 4. 13C-labelled urea breath test positive.
- 5.Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- 6.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 NSIAD or alcohol abusers.
- Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Trial locations and contacts
No sites are listed yet.
Youming Li, professor contact
About this study
Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out with the goal of improving H. pylori eradication and therapies have changed from single-antibiotic treatments to the current multi-antibiotic treatments. However, the eradication rate of H. pylori is still less than 80%. The reasons for this low eradication rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs, poor patient compliance or micro-environment in stomach. In this study, to obtain the higher eradication of H. pylori and discover the different mechanism between the current infection and refractory infection of H. pylori, it is necessary to perform a prevalence survey for eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
- Conditions
- Gastritis, Gastric Ulcer
- Being tested
- Antibiotic selection based on the antibiotic susceptibility testing, PPI selection based on the CYP2C19 gene polymorphism, Probiotics usage based on the 16SrRNA sequencing
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism, Cause
- Medical subject headings
- Gastritis, Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic selection based on the antibiotic susceptibility testingBiological
The biological intervention focused on the results from the antibiotic susceptibility testing. All patients should used the their susceptibility antibiotics according to antibiotic susceptibility testing of H. pylori. Considering the safety of drug usage, priority antibiotic selection was as follow: Amoxicillin > Clarithromycin > Levofloxacin >Tetracycline > Furazolidone > Metronidazole.
PPI selection based on the CYP2C19 gene polymorphismGenetic
PPI selection should based on the CYP2C19 gene polymorphism of patients. Patients have different metabolizers, such as poor metabolizers (PM), extensive metabolizers (EM) and intermediate metabolizer (IM). Different metabolism of patients should select different PPI or different doses of PPI. For IM and PM, in this study, patients selected the standard dose of Omeprazole. For EM, in this study, patients selected the Esomeprazole with increasing doses 50%-100%.
Probiotics usage based on the 16SrRNA sequencingDietary supplement
Different micro-environment in stomach may influence the antibiotic absorption. In this study, some patients could select probiotic as adjuvant therapy according to their micro-environment in stomach by 16SrRNA sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Successful treatment | Experimental | The patients with H. pylori infection have successful treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing. Receives: Biological: Antibiotic selection based on the antibiotic susceptibility testing; Genetic: PPI selection based on the CYP2C19 gene polymorphism; Dietary Supplement: Probiotics usage based on the 16SrRNA sequencing |
| refractory infection | Experimental | The patients with H. pylori infection have failed treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing. Receives: Biological: Antibiotic selection based on the antibiotic susceptibility testing; Genetic: PPI selection based on the CYP2C19 gene polymorphism; Dietary Supplement: Probiotics usage based on the 16SrRNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates
To investigate the eradication rates of H.Pylori after individual quadruple therapy based on antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
Measured: Three months
Mutation site of drug resistance gene
To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.
Measured: Three months
The distribution and proportion of microflora in stomach
To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing.
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 posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (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.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Nanfang Hospital, Southern Medical University, Third Affiliated Hospital of Third Military Medical University, The First Affiliated Hospital with Nanjing Medical University, Centers for Disease Control and Prevention, China, Academy Military Medical Science, China
- Responsible party
- Principal investigator, Youming Li, First Affiliated Hospital of Zhejiang University
- Investigators
- Youming Li, professor, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689583
- Sponsor's protocol ID
- FirstZhejiangU YMLi
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02689583
- Acronym / sponsor ID
- FirstZhejiangU YMLi
- Conditions
- Gastritis, Gastric Ulcer
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism, Cause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Nanfang Hospital, Southern Medical University, Third Affiliated Hospital of Third Military Medical University, The First Affiliated Hospital with Nanjing Medical University, Centers for Disease Control and Prevention, China, Academy Military Medical Science, China
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 24 Feb 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.
Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out with the goal of improving H. pylori eradication and therapies have changed from single-antibiotic treatments to the current multi-antibiotic treatments. However, the eradication rate of H. pylori is still less than 80%. The reasons for this low eradication rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs, poor patient compliance or micro-environment in stomach. In this study, to obtain the higher eradication of H. pylori and discover the different mechanism between the current infection and refractory infection of H. pylori, it is necessary to perform a prevalence survey for eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful treatment | Experimental | Biological: Antibiotic selection based on the antibiotic susceptibility testing, Genetic: PPI selection based on the CYP2C19 gene polymorphism, Dietary Supplement: Probiotics usage based on the 16SrRNA sequencingThe patients with H. pylori infection have successful treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing. |
| refractory infection | Experimental | Biological: Antibiotic selection based on the antibiotic susceptibility testing, Genetic: PPI selection based on the CYP2C19 gene polymorphism, Dietary Supplement: Probiotics usage based on the 16SrRNA sequencingThe patients with H. pylori infection have failed treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18~70 years old, male or female, untreated patients.
- Symptoms of abdominal pain, bloating, acid reflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks 4. 13C-labelled urea breath test positive.
- 5.Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- 6.Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
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 |
|---|---|---|
| Antibiotic selection based on the antibiotic susceptibility testingThe biological intervention focused on the results from the antibiotic susceptibility testing. All patients should used the their susceptibility antibiotics according to antibiotic susceptibility testing of H. pylori. Considering the safety of drug usage, priority antibiotic selection was as follow: Amoxicillin > Clarithromycin > Levofloxacin >Tetracycline > Furazolidone > Metronidazole. | Biological | Successful treatment, refractory infection |
| PPI selection based on the CYP2C19 gene polymorphismPPI selection should based on the CYP2C19 gene polymorphism of patients. Patients have different metabolizers, such as poor metabolizers (PM), extensive metabolizers (EM) and intermediate metabolizer (IM). Different metabolism of patients should select different PPI or different doses of PPI. For IM and PM, in this study, patients selected the standard dose of Omeprazole. For EM, in this study, patients selected the Esomeprazole with increasing doses 50%-100%. | Genetic | Successful treatment, refractory infection |
| Probiotics usage based on the 16SrRNA sequencingDifferent micro-environment in stomach may influence the antibiotic absorption. In this study, some patients could select probiotic as adjuvant therapy according to their micro-environment in stomach by 16SrRNA sequencing. | Dietary supplement | Successful treatment, refractory infection |
Primary outcome
Eradication rates
Time frame: Three months
To investigate the eradication rates of H.Pylori after individual quadruple therapy based on antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
Mutation site of drug resistance gene
Time frame: Three months
To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.
The distribution and proportion of microflora in stomach
Time frame: Three months
To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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.
Youming Li, professor contact
Youming Li, professor principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic selection based on the antibiotic susceptibility testing, PPI selection based on the CYP2C19 gene polymorphism and Probiotics usage based on the 16SrRNA sequencing in people with Gastritis and Gastric Ulcer, run by First Affiliated Hospital of Zhejiang University.
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 5 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Youming Li, professor (zlym@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rates (time frame: Three months). The study lists 3 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 24 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.