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

Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Functional Dyspepsia; Peptic Ulcer

Intervention: Bismuth (Drug); Lansoprazole (Drug); Levofloxacin (Drug); Amoxicillin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shanghai Jiao Tong University School of Medicine

Official(s) and/or principal investigator(s):
Hong Lu, Principal Investigator, Affiliation: Shanghai Jiao-Tong University School of Medicine Renji Hospital


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

Clinical Details

Official title: Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: eradication rate of Helicobacter pylori

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Shanghai Jiao-Tong University School of Medicine Renji Hospital, Shanghai, Shanghai 200127, China
Additional Information

Starting date: May 2012
Last updated: December 12, 2012

Page last updated: August 23, 2015

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