A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin

Summary

As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.

Conditions

• Gastritis

Interventions

DEVICE

The results of clarithromycin susceptibility test of H. pylori isolates

According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.

DEVICE

Computer generated random number, randomly assigned into groups

The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

DEVICE

The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups

The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.

Sponsors & Collaborators

• Wenzhou Central Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Affiliated Wenling Hospital of Wenzhou Medical University

  collaborator OTHER

• Hangzhou Medical College

  collaborator OTHER

• Centers for Disease Control and Prevention, China

  collaborator OTHER_GOV

• Zhiyuan Medical Inspection Institute

  collaborator OTHER

• Sanmen People's 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

2017-01-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• China

Study Locations