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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Peptic Ulcer; Functional Dyspepsia

Treatments: Drug: Bismuth; Drug: Levofloxacin; Drug: Lansoprazole; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01667718

rjkls2012011

Details and patient eligibility

About

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

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

Levofloxacin-triple therapy

Active Comparator group

Description:

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

Treatment:

Drug: Amoxicillin

Drug: Lansoprazole

Drug: Levofloxacin

Levofloxacin-quadruple therapy

Experimental group

Description:

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

Treatment:

Drug: Amoxicillin

Drug: Lansoprazole

Drug: Bismuth

Drug: Levofloxacin