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.

Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000493549

Enrollment

200

Registered

2015-05-19

Start date

2012-01-18

Completion date

2013-12-10

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary aim of this study is to determine Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.

Interventions

sequential treatment (5 days of rabeprazole 20 mg three times a day and bismuth subcitrate (BIS) 240mg four times a day, followed by 5 days of rabeprazole 20 mg three times a day, BIS 240mg four times a day, rifabutin (RFB) 150 mg twice a day and ciprofloxacin (CIP) 500 mg twice a day.); All drugs are to be taken orally; Patients compliance was checked via phone interview.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results