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Completed

NCT Number: NCT01667718

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

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

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Key information

Conditions

Functional Dyspepsia Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bismuth

Drug

Bismuth 220mg b.i.d for 2 weeks

Other names: Bismuth potassium citrate

Lansoprazole

Drug

Lansoprazole 30 mg b.i.d.for 2 weeks

Other names: Proton Pump Inhibitor

Levofloxacin

Drug

Levofloxacin 0.5 q.d. for 2 weeks

Amoxicillin

Drug

Amoxicillin 1 g b.i.d. for 2 weeks

Primary outcomes

  1. eradication rate of Helicobacter pylori

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2012
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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