Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

Phase 4

Completed

• Conditions: Functional Dyspepsia; Peptic Ulcer
• Interventions: Drug: Lansoprazole; Drug: Bismuth; Drug: Levofloxacin; Drug: Amoxicillin

• Registration Number: NCT01667718
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

Detailed Description

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-17
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria

• patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin-triple therapy	Amoxicillin	Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
Levofloxacin-triple therapy	Levofloxacin	Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
Levofloxacin-triple therapy	Lansoprazole	Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
Levofloxacin-quadruple therapy	Lansoprazole	Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
Levofloxacin-quadruple therapy	Levofloxacin	Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
Levofloxacin-quadruple therapy	Amoxicillin	Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
Levofloxacin-quadruple therapy	Bismuth	Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

Primary Outcome Measures

Name	Time	Method
eradication rate of Helicobacter pylori	2 months

Trial Locations

Locations (1)

Shanghai Jiao-Tong University School of Medicine Renji Hospital; 🇨🇳 Shanghai, Shanghai, China