A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection

February 23, 2016 updated by: Youming Li, First Affiliated Hospital of Zhejiang University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18~70 years old, male or female, untreated patients.
  2. Symptoms of abdominal pain, bloating, acid reflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
  3. 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.

Exclusion Criteria:

  1. Severe heart, liver, kidney dysfunction.
  2. Pregnant or lactating women.
  3. Complications of bleeding, perforation, pyloric obstruction, cancer.
  4. Esophageal,gastrointestinal surgery history.
  5. Patients can not properly express their complaints,such as psychosis, severe neurosis.
  6. Taking NSIAD or alcohol abusers.
  7. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Successful treatment
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.
Biological: Antibiotic selection based on the antibiotic susceptibility testing
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.
Genetic: PPI selection based on the CYP2C19 gene polymorphism
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%.
Dietary supplement: Probiotics usage based on the 16SrRNA sequencing
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.
Experimental: refractory infection
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.
Biological: Antibiotic selection based on the antibiotic susceptibility testing
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.
Genetic: PPI selection based on the CYP2C19 gene polymorphism
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%.
Dietary supplement: Probiotics usage based on the 16SrRNA sequencing
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Three months
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.
Three months
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.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
Peking Union Medical College Hospital
Nanfang Hospital of Southern Medical University
Academy Military Medical Science, China
Centers for Disease Control and Prevention, China
Third Affiliated Hospital of Third Military Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Youming Li, professor, First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FirstZhejiangU YMLi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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