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

Primary Purpose

Gastritis, Gastric Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Antibiotic selection based on the antibiotic susceptibility testing

PPI selection based on the CYP2C19 gene polymorphism

Probiotics usage based on the 16SrRNA sequencing

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism, Cause

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Successful treatment

refractory infection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02689583

First Posted

February 1, 2016

Last Updated

February 23, 2016

Sponsor

First Affiliated Hospital of Zhejiang University

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

1. Study Identification

Unique Protocol Identification Number

NCT02689583

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

4. Oversight

5. Study Description

Brief 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%. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastritis, Gastric Ulcer

Keywords

Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism, Cause

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Successful treatment

Arm Type

Experimental

Arm Description

Arm Title

refractory infection

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Antibiotic selection based on the antibiotic susceptibility testing

Intervention Description

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.

Intervention Type

Genetic

Intervention Name(s)

PPI selection based on the CYP2C19 gene polymorphism

Intervention Description

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%.

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotics usage based on the 16SrRNA sequencing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Eradication rates

Description

Time Frame

Three months

Title

Mutation site of drug resistance gene

Description

To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.

Time Frame

Three months

Title

The distribution and proportion of microflora in stomach

Description

To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing.

Time Frame

Three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Youming Li, professor

zlym@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Youming Li, professor

Organizational Affiliation

First Affiliated Hospital of Zhejiang University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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