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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • 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.

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

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
Intervention / Treatment
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

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

First Affiliated Hospital of Zhejiang University

Collaborators

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

  • 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

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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