Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: 5RA-5RCM; Drug: 5RA-5RCT; Drug: 10RCA

• Registration Number: NCT01573975
• Lead Sponsor: Buddhist Tzu Chi General Hospital

Brief Summary

The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Detailed Description

Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.

Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people.

Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori.

Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-09
• Last Update Submitted: 2012-04-09
• Study First Posted: 2012-04-10
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• patient proved with infection of H. pylori in gastric mucosa
• adult with signed inform consent

Exclusion Criteria

• woman in breast feeding or pregnancy.
• allergy to drugs used in study.
• three months without use of any antibiotic agents.
• patients under 20 years old.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seq-Metronidazole	5RA-5RCM	10-day sequential therapy with metronidazole
Seq-Tetracycline	5RA-5RCT	10-day sequential therapy with tetracycline.
Control	10RCA	10-day standard triple therapy.

Primary Outcome Measures

Name	Time	Method
Eradication rate	4 weeks after complete use of drug for treatment	A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment

Trial Locations

Locations (1)

Buddhist Tzu Chi General Hospital; 🇨🇳 Hualien, Taiwan