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

Not Applicable

• Conditions: Gastritis
• Interventions: Device: The results of clarithromycin susceptibility test of H. pylori isolates; Device: Computer generated random number, randomly assigned into groups; Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups

• Registration Number: NCT02923856
• Lead Sponsor: Sanmen People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Study Start: 2017-01
• Status Verified: 2018-08
• Last Update Submitted: 2019-02-16
• Last Update Posted: 2019-02-19
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 672

Inclusion Criteria

1. Age 18~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
2. Symptoms of abdominal pain, bloating, acid efflux, 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. Within 3 months before with the drugs involved in other drugs research.
5. Esophageal,gastrointestinal surgery history.
6. Patients can not properly express their complaints,such as psychosis, severe neurosis.
7. Taking NSIAD or alcohol abusers.
8. Allergic to amoxicillin or clarithromycin tested by susceptibility testing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 days failed treatment	The results of clarithromycin susceptibility test of H. pylori isolates	The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
Clarithromycin resistance group	The results of clarithromycin susceptibility test of H. pylori isolates	Patients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group.
7 days failed treatment	Computer generated random number, randomly assigned into groups	The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
10 days Successful treatment	Computer generated random number, randomly assigned into groups	The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
7 days Successful treatment	Computer generated random number, randomly assigned into groups	The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
7 days Successful treatment	The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups	The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
7 days failed treatment	The results of clarithromycin susceptibility test of H. pylori isolates	The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
10 days Successful treatment	The results of clarithromycin susceptibility test of H. pylori isolates	The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
14 days Successful treatment	Computer generated random number, randomly assigned into groups	The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
14 days Successful treatment	The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups	The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
14 days failed treatment	Computer generated random number, randomly assigned into groups	The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
7 days Successful treatment	The results of clarithromycin susceptibility test of H. pylori isolates	The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
7 days failed treatment	The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups	The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
10 days Successful treatment	The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups	The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
10 days failed treatment	Computer generated random number, randomly assigned into groups	The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
14 days failed treatment	The results of clarithromycin susceptibility test of H. pylori isolates	The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
10 days failed treatment	The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups	The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
14 days Successful treatment	The results of clarithromycin susceptibility test of H. pylori isolates	The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
14 days failed treatment	The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups	The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.

Primary Outcome Measures

Name	Time	Method
Establish individualized precision triple therapy based on minimal inhibitory concentration.	2.5 years	Based on the clarithromycin accurate susceptibility，pinpoint different courses of triple treatment therapy targeted to different people based on minimal inhibitory concentration of clarithromycin.
The accurate determination of clarithromycin susceptibility.	2 years	Assess bacterial susceptibility to antibiotics using the agar diffusion method. The Resistance point of clarithromycin was divided into 0.125μg/ml,0.25μg/ml,0.5μg/ml and 1μg/ml.Test clarithromycin resistance of Helicobacter pylori for patients.

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse effects	3 years	Drugs targeted, it could reduce the intake of antibiotics for patients.The incidence of adverse effects in the eradicate treatment will reduce. Avoid patients' unnecessary economic losses.

Trial Locations

Locations (1)

Sanmen People's hospital; 🇨🇳 Taizhou, Zhejiang, China