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Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01667575
Enrollment
180
Registered
2012-08-17
Start date
2012-08-31
Completion date
2013-05-31
Last updated
2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia, Helicobacter Pylori, Peptic Ulcer

Brief summary

The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Detailed description

The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Interventions

DRUGEsomeprazole

antisecretary drug of the quadruple therapy

DRUGAmoxicillin

antibiotic of the quadruple therapy

DRUGClarithromycin

antibiotic of the quadruple therapy

DRUGBismuth Potassium Citrate

one of a component of a quadruple therapy

OTHERlong duration (14 day)

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rate of Helicobacter pylori2 monthsTo calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026