A Multi-center Study for Eradication of Refractory Helicobacter Pylori

Summary

Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. pylori is still existing, although patients have good compliance and receive standardized treatment. This phenomenon is likely attributed to the different ratio of sensitive and resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. In order to solve the refractory infection of H. pylori, investigators performed a muti-center study together with other 14 institutions. In this study, investigators will select the patients with refractory infection of H. pylori after two standardized treatment from patients with first eradication therapy of H. pylori infection. Then, investigators will perform a high-throughput sequencing for patients in groups. Finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.

Conditions

• Gastritis

Interventions

DEVICE

The result of H pylori culture based on gram staining and enzyme activity testing

This intervention aimed at patients with the positive result of 13C-urea breath test. Patients with negative result of H pylori culture was H pylori culture negative group. Patients with positive result of H pylori culture were belonged into the first successful eradication group and the refractory infection of H. pylori group.

DEVICE

The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole

The intervention focused on the results from the result of 13C-urea breath test after treatment. The first successful eradication group and the refractory infection of H. pylori group were treated according to the antibiotic susceptibility testing and CYP2C19 gene polymorphism. Eight weeks after treatment, a 13C-urea breath test was performed on patients. The first successful eradication group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients with positive in 13C-urea breath tests after the second standardized treatment.

DEVICE

The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing

The intervention focused on the results from the result of Amoxicillin susceptibility testing in vitro. In this study, the investigators selected the patients with Amoxicillin resistance from the first successful eradication group and the refractory infection of H. pylori group.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China

  collaborator OTHER_GOV

• Academy Military Medical Science, China

  collaborator INDUSTRY

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Taizhou Enze Medical Center Group

  collaborator OTHER

• Taizhou First People's Hospital

  collaborator OTHER

• The first people Hospital of Linhai

  collaborator UNKNOWN

• Affiliated Wenling Hospital of Wenzhou Medical University

  collaborator OTHER

• Sanmen People Hospital

  collaborator UNKNOWN

• Xianju People Hospital

  collaborator UNKNOWN

• Tiantai People Hospital

  collaborator UNKNOWN

• Yuhuan People Hospital

  collaborator UNKNOWN

• The second people Hospital of Yuhuan

  collaborator UNKNOWN

• Zhiyuan Medical Inspection Institute

  collaborator OTHER

• Taizhou Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2018-04-30

Completion

2018-12-31

Countries

• China

Study Locations