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

NCT ID: NCT02689583

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31

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.

Conditions

Gastritis; Gastric Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Antibiotic selection based on the antibiotic susceptibility testing

Intervention Type: BIOLOGICAL

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 polymorphism

Intervention Type: GENETIC

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 sequencing

Intervention Type: DIETARY_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.

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.

Group Type: EXPERIMENTAL

Antibiotic selection based on the antibiotic susceptibility testing

Intervention Type: BIOLOGICAL

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 polymorphism

Intervention Type: GENETIC

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 sequencing

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: BIOLOGICAL

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%.

Intervention Type: GENETIC

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital of Third Military Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: collaborator

Academy Military Medical Science, China

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Youming Li

Director of the Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youming Li, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Central Contacts

Youming Li, professor

Role: CONTACT

zlym@zju.edu.cn

Other Identifiers

FirstZhejiangU YMLi

Identifier Type: -

Identifier Source: org_study_id