Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing

Treatments: Drug: two antibiotics for failed eradication(tetracyclin,furazolidone); Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline); Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone); Drug: one proton pump inhibitor(PPI); Drug: Colloidal Bismuth Pectin

Study type: Interventional

Funder types: Other

Identifiers

NCT03571230

2017SDU-QILU-G003

Details and patient eligibility

About

The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

Full description

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the first-line treatment.

Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-70 with H. pylori infection.

Exclusion criteria

• Patients with previous H. pylori eradication therapy;
• Patients unable or unwilling to receive gastroscopy;
• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks;
• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
• Patients with known or suspected allergy to study medications;
• Currently pregnant or lactating;
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 4 patient groups

Antimicrobial susceptibility testing guided therapy

Experimental group

Description:

Patients in this group will receive a 10-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.

Treatment:

Drug: one proton pump inhibitor(PPI)

Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)

Empirical tailored therapy

Experimental group

Description:

Patients in this group will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Treatment:

Drug: one proton pump inhibitor(PPI)

Drug: Colloidal Bismuth Pectin

Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)

Salvage therapy for negative culture

Other group

Description:

When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Treatment:

Drug: one proton pump inhibitor(PPI)

Drug: Colloidal Bismuth Pectin

Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)

Salvage therapy for failed eradication

Other group

Description:

If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid and furazolidone 100mg bid for 14d.

Treatment:

Drug: one proton pump inhibitor(PPI)

Drug: two antibiotics for failed eradication(tetracyclin,furazolidone)

Drug: Colloidal Bismuth Pectin