Susceptibility based Fourth-line eradicatio

Phase 2

Completed

• Conditions: Helicobacter pylori infection; Helicobacter pylori

• Registration Number: JPRN-jRCTs031180208
• Lead Sponsor: Sue Soichiro

Brief Summary

The susceptibility testing based fourth-line Helicobacter pylori eradication therapy showed efficacy with 63.2% (95%CI: 38.4-83.7%) eradication rate in FAS analysis and 70.6% (95%CI: 44.0-89.7%) eradication rate in PPS analysis. There is no problem in safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Study Completion: 2021-04-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

A patient with Helicobacter pylori infection failed for first, second (one week triple therapy with acid suppressant and amoxicillin and clarithromycin or metronidazole) and sitafloxacin based third line eradication .
A patient who was diagnosed for Helicobacter pylori infection by urea breath test or Helicobacter pylori stool antigen test.
A patient who can perform urea breath test after 8 weeks from treatment completion.
A patient who give a written informed consent.

Exclusion Criteria

A patient who don't agree for endoscopy and susceptible testing as own expense medical care before eradication therapy.
Past history of allergy or side effect requiring treatment for the drugs used in this study.
Pregnancy or lactation. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by physicians.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication rate

Secondary Outcome Measures

Name	Time	Method
Adverse event by questionnaire