Cure rate and side effects comparison between the sequential bismuth based quadruple therapy and the concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.
Phase 4
Completed
- Conditions
- Infection - Studies of infection and infectious agentsHelicobacter pylori unable to be eradicated with standard triple therapies.Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12615000493549
- Lead Sponsor
- niversity of Western Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Patients must fail more than one standard triple therapy, which indicate carrying antibiotic resistant H. pylori strain.
If antibiotic sensitivity testing was performed, the strain must be sensitive to Ciprofloxacin and Rifabutin.
Exclusion Criteria
free of H. pylori infection, mental disability, pregnancy or lactation in women, known allergy or hypersensitivity to drugs used in study therapy, or current participation with other clinical trials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success, assessed by percentage of cured patients.[Because the followup diagnosis of these patients can vary from a month to several months and the rarity of reinfection of this organism, we would accept all patient's follow up diagnostic results up to two years.]
- Secondary Outcome Measures
Name Time Method side effects comparison between the test group (sequential quadruple therapy) and the control group (concomitant quadruple therapy).<br><br>side effects data are collected based on a 5 min survey designed specifically for this study.<br><br>Most common side effects include, nausea, diarrhea, stomach pain, headache and dry mouth.[survey is given immediately after completion of treatment. ]